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We get it. You just want to innovate medical devices.

We know you want to focus on making the world's best medical devices.
Not filling out forms.
Or man-handle Excel trace tables.
Or slowly wither away in endless review meetings.

We loved creating medical devices. It's exciting, it's innovative, and it feels good to know we're helping people's health.
But, boy, the Technical Documentation...

We had top-notch tools for engineering, but when it came to documentation, we were stuck with Word and Excel.
And let's be honest, the results weren't great. Auditors kept finding mistakes, no matter how many times we checked our work.

That's why we decided to take action.
In 2006, we set out to create Aligned Elements — a solution designed to make Technical File creation more efficient and free from errors.
Since then, we've continuously refined our approach based on feedback from our clients, ensuring that our tools meet their evolving needs as Medical Device Manufacturers.

At Aligned, we're on a mission to streamline the way Technical Documentation is handled in the medical device industry, ensuring compliance with industry standards such as FDA QSR 820 and EU MDR/IVDR. Founded by a team of experienced medical device developers, we understand the challenges of medical device Technical Documentation first-hand.

Form

Our goal is simple: to help you spend less time on paperwork and more time on what matters most — developing groundbreaking medical devices. With Aligned Elements, you can navigate regulatory requirements with ease, confident that your documentation is accurate and compliant.

So, let's work together to simplify technical documentation and unleash your full potential for innovation.

At Aligned, we're here to support you every step of the way!

Start your Free Aligned Elements Trial today!

Video Recordings from Sharpen Your Skills 2023 - Part 2

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Thank you very much for joining us last Tuesday!

Find the recordings of the four expert sessions below. See you again next year!

Session Recordings

Four things the e-STAR template teaches us about digitalization

Presented by: Thomas Bohnen, CEO, KEYMKR

Unveiling FDA's new Computer Software Assurance: What Lies Beneath the Surface!



Presented by: Peter Roka, MedTech Consultant, QUAREGIA

How to avoid Death by Documentation?

Presented by: Karl Larsson, MSc, MBA, Technical File Specialist and co-founder of Aligned AG

Free Online Medical Device Development Seminar - Sharpen your skills 2023 - Part 2

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Tuesday September 26th, 2023 | 14:00 - 16:15 CET | Free Online Medical Device Development Seminar


Aligned Seminar

Compliant and Efficient Medical Device Development

An impossible combination? 

We provide concrete and practical advice on how to meet common and urgent medical device development challenges.

Meet our group of experienced industry experts to share their latest best practices on how to eliminate problems with you.

Register now to reserve your seat!

Register on Linked In: https://www.linkedin.com/events/freeonlinemedicaldevicedevelopm7105283703521558528/

We look forward to seeing you at this event. If you have any questions or information requests, please don't hesitate to This email address is being protected from spambots. You need JavaScript enabled to view it.

 


Key Learning Objectives

Four things the e-STAR template teaches us about digitalization

On the surface, the FDA eSTAR interactive PDF form was introduced by FDA to speed up the submission process for medical device manufacturers. 

But does it?  What else comes with it? Is it a threat or an opportunity?

After having created dozens of submissions in the PDF era, we see distinct differences in using the eSTAR template. And these go far beyond the introduction of a new submission format. We have made important insights that we want to share with you.  

Presented by: Thomas Bohnen, CEO, KEYMKR

Unveiling FDA's new Computer Software Assurance: What Lies Beneath the Surface!

In the previous year, the FDA unveiled a novel methodology for validating computerized systems in medical device production and quality systems, known as Computer Software Assurance (CSA).

Explore how this stands apart from the conventional Computer System Validation (CSV) method.

How might you adapt your current processes in light of these changes? Additionally, what benefits can you expect from transitioning to CSA?

Presented by: Peter Roka, MedTech Consultant, QUAREGIA

How to avoid Death by Documentation?

Creating and organizing documents may not seem like rocket science, but compiling Technical Files according to MDR, ISO 13485 and FDA QSR 820 is remarkably cumbersome.

This seminar highlights how great savings can be made, using sound structures and digital tools.

We uncover bad documentation practices, their consequences, and potential remedies with the intent to make the medical device documentation process more efficient.

Presented by: Karl Larsson, MSc, MBA, Technical File Specialist and co-founder of Aligned AG


Time and Place

  • Date: Tuesday, September 26th
  • Time: 14:00 - 16:15 CET
  • Live Streamed from the Aligned HQ. The Teams link is on the Linked In Event page.

Presentations are held in English.

Target audience

This event is aimed at medical device development professionals, project managers, QARA professionals, R&D personnel, and other industry professionals engaged in medical device development.

Registration

Register to get your online access. We are looking forward to seeing you in this virtual seminar!

 


About Aligned AG

Aligned AG provides Aligned Elements, a Medical Device ALM system that accelerates and ensures compliant Design Control documentation for medical devices. We assist our clients in developing regulatory compliant products within shorter time-frames, to lower costs and with higher confidence. 

This event is a collaboration between Aligned AG and Health Tech Cluster Switzerland.

 

Video Recordings from Sharpen Your Skills 2023

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We are very excited about the many engaged participants joining us last Tuesday!

Aligned's Sharpen Your Skills event proves to be worth a visit once again!

Find the recordings of the four expert sessions below. See you again next year!

Session Recordings

Why Medical Device Companies are Rubbish at Requirements

Presented by:  Peter Sebelius, CEO and Consultant, Medical Device HQ

If everyone comes first - they all come last! Escaping the Risk PMS / Clinical Deadlock



Presented by: Stefan Bolleininger, CEO, be-on-quality GmbH

 

Post-Market Surveillance under MDR (IVDR) – not a regulatory burden only

Presented by: Werner Knopp, Managing Director, Keymkr GmbH

Documenting Cyber Security in Design Controls and Traceability

Presented by: Karl Larsson, MSc, MBA, Technical File Specialist and co-founder of Aligned AG

Free Online Medical Device Development Seminar - Sharpen your skills 2023 - Part 1

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Tuesday May 9th, 2023 | 13:30 - 16:30 CET | Free Online Medical Device Development Seminar


Aligned Seminar

Compliant and Efficient Medical Device Development

An impossible combination? 

We provide concrete and practical advice on how to meet common and urgent medical device development challenges.

Meet our group of experienced industry experts to share their latest best practices on how to eliminate problems with you.

Register now to reserve your seat!

Register on Linked In: https://www.linkedin.com/events/7054018013661949952

We look forward to seeing you at this event. If you have any questions or information requests, please don't hesitate to This email address is being protected from spambots. You need JavaScript enabled to view it.

 


Key Learning Objectives

Why Medical Device Companies are Rubbish at Requirements

After having had thousands of people write requirements during my design control courses, I am not impressed. Requirements engineering appears to be seen only as a regulatory requirement, not something that is value-adding.

This will be a crash course on requirements engineering for medical devices, including how to write user needs and design input requirements.

Presented by: Peter Sebelius, CEO and Consultant, Medical Device HQ

If everyone comes first - they all come last! Escaping the Risk PMS / Clinical Deadlock

MDR has huge demands on our documentation system as well as on the integrity of this system. Errors can have significant consequences in the filing of our devices.

This is particularly true when working with automated procedures for approval workflows or with distributed engineering teams, which care about their individual documentation tasks and the interactions needed to fulfil them. As a consequence, the documentation release takes too much effort to get the line tight and clean. 

Based on implementation of timing diagrams, we want to show options to set up the sync-points, synchronization issues to get effective roll-outs.

Presented by: Stefan Bolleininger, CEO, be-on-quality GmbH

Post-Market Surveillance under MDR (IVDR) – not a regulatory burden only

Despite the burdensome regulatory requirements in terms of post-market surveillance of medical devices (and in-vitro diagnostic devices), the manufacturer actually has a great opportunity to create value-adding data during the PMS. With a well-planned strategy, where the manufacturer makes conscious choices when applying the available state-of-the-art methods, questions of concern, data sources and methods, an increased knowledge about the devices within the post-market phase will ensue.

This session will provide an idea of a value-creating, dynamic PMS, showing how this activity is not a regulatory burden only.

Presented by: Werner Knopp, Managing Director, Keymkr GmbH

Documenting Cyber Security in Design Controls and Traceability

The large amounts of Cyber Security standards and guidances released for medical device development during the last few years reflects the increased importance of this domain. But how do medical device manufacturers implement these guidances, and how are they documented in real life? 

In this talk, we will look at a number of examples and approaches that reflect how companies chose to implement Cyber Security for Medical Devices.

Presented by: Karl Larsson, MSc, MBA, Technical File Specialist and co-founder of Aligned AG


Time and Place

  • Date: Tuesday, May 9th
  • Time: 13:30 - 16:30 CET
  • Live Streamed from the Aligned HQ. The Teams link is on the Linked In Event page.

Presentations are held in English.

Target audience

This event is aimed at medical device development professionals, project managers, QARA professionals, R&D personnel, and other industry professionals engaged in medical device development.

Registration

Register to get your online access. We are looking forward to seeing you in this virtual seminar!

 


About Aligned AG

Aligned AG provides Aligned Elements, a Medical Device ALM system that accelerates and ensures compliant Design Control documentation for medical devices. We assist our clients in developing regulatory compliant products within shorter time-frames, to lower costs and with higher confidence. 

This event is a collaboration between Aligned AG and Health Tech Cluster Switzerland.

 

Video Recordings from Sharpen Your Skills 2022 - Part 2

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We are very excited about the many engaged participants joining us last Thursday!

Aligned's Sharpen Your Skills event proves to be worth a visit once again!

Find the recordings of the four expert sessions below. See you again next year!

Session Recordings

How to obtain your MDR certificate - Secrets from the Inside

Presented by: Pontus Gedda, former Technical Manager and Auditor at Intertek, Medical Device Specialist

Formative and summative Usability Evaluations – how to identify use problems and take advantage of them



Presented by: Dr.-Ing. Benedikt Janny, CEO, USE-Ing. GmbH

 

Enter the Dragon - How to get approval for a Medical Device Software in China

Presented by: Sonja Biernatzki, Regulatory Affairs Manager at Roche Diagnostics

How do you identify ALL risks?

Presented by: Karl Larsson, MSc, MBA, Technical File Specialist and co-founder of Aligned AG

Aligned at Medical Mountains in Tuttingen - Meet us on Oct 6th

Be it technical documentation or risk assessments: Could these activities be completed faster and more efficiently at the click of a mouse?

There is a whole range of digital tools available for medical technology that can save resources and increase safety and Aligned Elements is one of them.

We and 15 other digital tool providers will present what is already possible at the Information Event of Opportunities.

Date: October 6th, 10:00-15:00

Place: Stadthalle Tuttlingen 

MedicalMountains Logo

Visit us at and get to know digital solutions for regulatory affairs and quality management, talk to us and other providers and take away concrete tools, tips and best practice examples.

Looking forward to see you there!

 

Free Online Medical Device Development Seminar - Sharpen your skills 2022 - Part 2

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Thursday October 27th, 2022 | 13:30 - 16:30 CET | Free Online Medical Device Development Seminar


Aligned Seminar

Compliant and Efficient Medical Device Development

An impossible combination? 

We provide concrete and practical advice on how to meet common and urgent medical device development challenges.

Meet our group of experienced industry experts to share their latest best practices on how to eliminate problems with you.

Register now to reserve your seat!

Register on Linked In: https://www.linkedin.com/events/6980537339953479681

We look forward to seeing you at this event. If you have any questions or information requests, please don't hesitate to This email address is being protected from spambots. You need JavaScript enabled to view it.

 


Key Learning Objectives

How to obtain your MDR certificate - Secrets from the Inside

Getting an MDR certificate has become the focus of the majority of medical device manufacturers. As everyone are scrambling for an opportunity to submit their documentation, it becomes paramount to make sure that the technical documentation is complete and consistent. But is this sufficient?  

A former Notified Body Auditor gives you insights on how an application is processed and assessed and what you can learn from it. Find out about common pitfalls, best practices, and the fastest way to get to your CE mark.

Presented by: Pontus Gedda, former Technical Manager and Auditor at Intertek, Medical Device Specialist

Formative and summative Usability Evaluations – how to identify use problems and take advantage of them

Formative and summative evaluations are the heart of the Usability Engineering Process for medical devices and software. They are not only essential for the compliance with IEC 62366 but also a tremendous opportunity to fine-tune the design of the device.  

Learn how to target Usability Evaluations to generate maximum benefit and accelerate your medical product development process.

Presented by: Dr.-Ing. Benedikt Janny, CEO, USE-Ing. GmbH

Enter the Dragon - How to get approval for a Medical Device Software in China

With 1.3 billion residents, China is one of the largest medical device markets and a tremendous potential for western medical device manufacturers. But what does it take to accommodate China’s National Medical Products Administration (NMPA) and get the regulatory approvals necessary?

Learn more about how NMPA compares and contrasts to regulations like MDR or FDA from an expert that has already made this journey.

Presented by: Sonja Biernatzki, Regulatory Affairs Manager at Roche Diagnostics

How do you identify ALL risks?

ISO 14971 forces medical device manufacturers to think about all the characteristics that could affect safety. But how do you demonstrate that you have "thought of all charachteristics"? How do you make sure that no risks were missed? How do you argue that you have successfully completed the task of risk identification?

In this talk, we will use examples to explore various methods of risk identification and demonstrate how digital tools can make this process simple and efficient.

Presented by: Karl Larsson, MSc, MBA, Technical File Specialist and co-founder of Aligned AG


Time and Place

  • Date: Thursday, October 27th
  • Time: 13:00 - 16:30 CET
  • Live Streamed from the Aligned HQ. The Zoom link is on the Linked In Event page.

Presentations are held in English.

Target audience

This event is aimed at medical device development professionals, project managers, QARA professionals, R&D personnel, and other industry professionals engaged in medical device development.

Registration

Register to get your online access. We are looking forward to seeing you in this virtual seminar!

 


About Aligned AG

Aligned AG provides Aligned Elements, a Medical Device ALM system that accelerates and ensures compliant Design Control documentation for medical devices. We assist our clients in developing regulatory compliant products within shorter time-frames, to lower costs and with higher confidence. 

This event is a collaboration between Aligned AG and Health Tech Cluster Switzerland.

 HTCS

Video Recordings from Sharpen Your Skills 2022

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We are very excited about all the participants that joined us during our most recent seminar!

Aligned's Sharpen Your Skills event proves to be worth a visit once again!

Find the recordings of the four expert sessions below. See you again in the fall!

Session Recordings

How to transform a PMCF study to a business opportunity

Presented by: Mikaël Chelli, MD, MSc, Co-founder, EasyMedStat

Artificial intelligence (AI) Medical Devices on the EU market under MDR – impossible! Or is it?

Presented by: Roger Abächerli, Main Lecturer and Professor for MedTech, Institute for Medical Engineering IMT, HSLU

Navigate the risk management maze: Benefit-risk analysis made easy



Cristina Barkman, co-author of ISO 14971:2019 and ISO/TR 24971:2020, senior consultant at QAdvis AB

 

Traceability - If you don't know where you're going, you are probably not going to get there

Presented by: Anders Emmerich, MSc, CEO and co-founder of Aligned AG

Video Recordings from Sharpen Your Skills 2021 - Part 2

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We are very excited about the hundreds of participants joining us during our most recent seminar!

Aligned's Sharpen Your Skills event proves to be worth a visit once again!

Find the recordings of the three expert sessions below. See you again next year!

Session Recordings

SaMD Development is easy, right?

 

Presented by: Christian Kaestner, Medical Device HQ

No Risk, No Fun - More Risk, More Gain!



Presented by: Dr. Dirk Hüber, Congneius

 

Two for the price of One - Using Task Flow Analysis to create your IEC 62366 Use Scenarios

Presented by: Karl Larsson, Aligned AG

Free Online Medical Device Development Seminar - Sharpen your Skills 2 - 2021

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November 23rd, 2021 | 15:00 - 17:15 CET | Free Online Medical Device Development Seminar


Aligned Seminar

Compliant and Efficient Medical Device Development

An impossible combination? 

We provide concrete and practical advice on how to meet common and urgent medical device development challenges.

Meet our group of experienced industry experts to share their latest best practices on how to eliminate problems with you.

Register now to reserve your seat!

Register on Linked In: https://www.linkedin.com/events/6861944311781588992/

We look forward to seeing you at this event. If you have any questions or information requests, please don't hesitate to This email address is being protected from spambots. You need JavaScript enabled to view it.

 


Key Learning Objectives

SaMD Development is easy, right?

Developing a software-only medical device is by many perceived as complicated and sometimes even overwhelming! The rigid regulations and numerous standards governing medical device development seems to stand in stark conflict with the rapid-evolving design practices and emerging technologies that lie at the heart of software development.   

In this webinar, we will compare and contrast the development of SaMD devices with more traditional medical devices. You will learn how to handle challenges unique to SaMD development, in the large and small.

Presented by: Christian Kaestner, co-author of IEC 62304 and IEC 82304-1, expert at Medical Device HQ 

No Risk, No Fun - More Risk, More Gain!

To develop and maintain a risk management file always means a lot of effort. How can we ensure that we get the maximum gain for this effort? 

Join us for a deep dive into medical device risk management, its principles and the underlying intentions, and present an approach how to implement state-of-the-art risk management for medical devices. Make no mistake: risk management remains a large effort if you follow this approach. However, with a deeper understanding you will be able to leverage more from this effort, and will experience that risk management sessions may be fun!

Presented by: Dr. Dirk Hüber, Head of Quality, Congenius

Two for the price of One - Using Task Flow Analysis to create your IEC 62366 Use Scenarios 

Use Scenarios are the starting point of any IEC 62366 driven usability effort when applying Human Factors and Usability Engineering to medical devices.

But what method shall I use to identify and structure the Use Scenarios for my medical device?

Discover Task Flow Analysis, an efficient and collaborative technique used in several industries to not only identify and describe critical tasks, but also as a useful tool to uncover usability related hazards. This method elegantly describes the context in which the device is used and has a number of benefits that will accelerate your medical device development documentation. 

Learn from this session about the processes, techniques, and tool support available for successful IEC 62366 Use Scenario design.

Presented by: Karl Larsson, Medical Device Documentation Expert, Aligned AG


Time and Place

  • Date: Tuesday, November 23rd
  • Time: 15:00 - 17:15 CET
  • Live Streamed from the Aligned HQ. Sign up to get your access link!

Presentations are held in English.

Target audience

This event is aimed at medical device development professionals, project managers, QARA professionals, R&D personnel, and other industry professionals engaged in medical device development.

Registration

Register to get your online access. We are looking forward to seeing you in this virtual seminar!

 


About Aligned AG

Aligned AG provides Aligned Elements, a Medical Device ALM system that accelerates and ensures compliant Design Control documentation for medical devices. We assist our clients in developing regulatory compliant products within shorter time-frames, to lower costs and with higher confidence. 

This event is a collaboration between Aligned AG and Health Tech Cluster Switzerland.

 HTCS



Meet us at the Swiss Medtech Expo in Luzern!

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Das Aligned Team ist am 14. und 15. September 2021 auf der Swiss Medtech Expo.

Wir laden Sie herzlich zu einer guten Tasse Kaffee und einem Gespräch über die neusten Trends in der Dokumentation von Medizinprodukten ein.

Sie finden uns in Halle 2 auf dem Stand E 2139.

Swiss Med Tech Expo

Auch sollten Sie auf keinen Fall den Vortrag von Aligned Managing Director Karl Larsson zum Thema Find and eliminate errors in your Technical Documentation versäumen.

Dieser wird am Mittwoch, 15. September um 11:00 Uhr im Rahmen des Innovation Symposium stattfinden. Wir freuen uns auf Sie!

Video Recordings from Sharpen Your Skills 2021

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We are very excited for the big turn out on the 2021 edition of Aligned's Sharpen Your Skills event! It was a great show and a great crowd!

Find the recordings of the five expert sessions below. See you again next year!

Session Recordings

 

The secret life of Medical Device Development


Presented by: Mike Heald, CEO, Commala Ltd.


Demystifying software risk management



Presented by: Christian Kaestner, co-author of IEC 62304 and IEC 82304-1, trainer at Medical Device HQ

 

Human-centered development as a driver of medical product innovation


Presented by: Dr.-Ing. Benedikt Janny, CEO, USE-Ing. GmbH

EUDAMED - how bad can it be?

Presented by: Richard Houlihan, CEO, Eudamed Ltd, former technical manager for Eudamed 2 and MDR EUDAMED July 2017 - April 2019

Finding, eliminating, and avoiding errors in Design Control Documentation

Presented by: Karl Larsson, Medical Device Documentation Expert, Aligned AG

Listen to Aligned's CEO Anders Emmerich on "Mindset Impossible?"

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On Thursday this week (Thu 11th, 1:30 PM - 2:30 PM), our CEO Anders Emmerich, talks at the "Mindset Impossible?" online event about the history, trends, and patterns in the digital transformation currently sweeping the medical device industry.

You can join this zoom - event. Register and get log-in details here.

The event is hosted by Digital Chameleon, a consultancy for digital transformation in the healthcare and life science sector.

 

Free Online Medical Device Development Seminar - Sharpen your Skills 2021

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April 13th, 2021 | 09:00 - 12:15 | Free Online Medical Device Development Seminar


Compliant and Efficient Medical Device Development

An impossible combination? 

Join us to gather concrete and practical advice on how to meet trending medical device development challenges in 2021.

We have called on a group of experienced industry experts to share their latest best practices on how to eliminate problems with you.

Register now to reserve your seat!

Register on Linked In: https://www.linkedin.com/events/freeonlinemedicaldevicedevelopm6773634480822353921 

We look forward to seeing you at this event. If you have any questions or information requests, please don't hesitate to This email address is being protected from spambots. You need JavaScript enabled to view it.

 


Key Learning Objectives

The secret life of Medical Device Development

Let me take you on a holistic walk through the act of developing a medical device, joining dots rather than picking on a discrete activity.
There is a lot of common sense that underpins the regulation but it seems lost in both presentation and interpretation.
Taking a step back and asking: “Why are we doing this?” can help you to see the woods beyond the regulatory trees.

Presented by: Mike Heald, CEO, Commala

Demystifying software risk management

Medical device software risk management is often perceived as complicated to understand and work with – it is not!
In this seminar, you will not only get the foundational understandings, but you will also understand how to practice medical device software risk management!

Presented by: Christian Kaestner, co-author of IEC 62304 and IEC 82304-1, trainer at Medical Device HQ 

Human-centered development as a driver of medical product innovation

If you want to create medical devices that people love, then usability, user experience (UX), and ergonomics is the road forward.
We will describe how you can establish a human-centered development process and how using prototypes with real users during the early stages can provide new and powerful insights.
We will explore the usability and human factors engineering regulatory underpinnings and their relation to ISO 13485.
We will dissect which types of use-related risks exist and how they can be analysed according to ISO 14971 during your product development.

Presented by: Dr.-Ing. Benedikt Janny, CEO, USE-Ing. GmbH

EUDAMED - how bad can it be?

If you thought you had covered Eudamed by implementing UDI's, then think again!
In this talk, we will address the deliverables required by medical device manufacturers, how to use medical device codes, how to communicate with the Eudamed servers.
We'll describe how to deal with legacy devices and how you can best organize your work to efficiently meet the Eudamed challenges ahead.

Eudamed is coming for you. We will help you prepare.

Presented by: Richard Houlihan, CEO, Eudamed Ltd, former technical manager for Eudamed 2 and MDR EUDAMED July 2017 - April 2019 

Finding, eliminating, and avoiding errors in Design Control Documentation - before audits and submissions

Having spent years developing and documenting a medical device just to get it rejected by a Notified Body or the FDA is a costly and disheartening experience.
Are there other ways than lengthy reviews to find and eliminate inconsistencies in your Technical Documentation?
Learn from this session about strategies, techniques, and methods for finding, eliminating, and avoiding errors in your Technical File.

Presented by: Karl Larsson, Medical Device Documentation Expert, Aligned AG


Time and Place

  • Date: Tuesday, April 13th
  • Time: 09:00 - 12:15
  • Live Streamed from the Aligned HQ. Sign up to get your access link!

Presentations are held in English.

Target audience

This event is aimed at medical device development professionals, project managers, QARA professionals, R&D personnel, and other industry professionals engaged in medical device development.

Registration

Register to get your online access. We are looking forward to seeing you in this virtual seminar!

 


 

About Aligned AG

Aligned AG provides Aligned Elements, a Medical Device ALM system that accelerates and ensures compliant Design Control documentation for medical devices. We assist our clients in developing regulatory compliant products within shorter time-frames, to lower costs and with higher confidence. 

This event is a collaboration between Aligned AG and Health Tech Cluster Switzerland.

 HTCS

 

Aligned at MedConf 2020 21-23 October

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In just a few weeks you can meet us at MedConf2020 in Munich!
If you do not want to travel that far, you can benefit from this year's Hybrid event! All participants can follow the lectures and keynotes remotely just as well as on-site!


On Thursday, October 23. 13:30 - 14:15, our Design Control Management Expert Karl Larsson will present "The hidden treasure in your Technical Documentation".

Read more about the full agenda here.

We look forward to your participation! Sign up today!

Videos and presentations from Sharpen Your Skills 2020

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We are very thankful for the engaging participation of all medical device colleagues in this year's Sharpen Your Skills event.

Videos and Slides

Perspective of Post-Market Surveillance under MDR

 

Download slides here.

Presented by: Linda Ahnen, PhD, Project Associate, Medidee

When to test what and why. A true story from a developer’s perspective. 

 

 

Download slides here.

Presented by: Dr. Thomas Degen, Dozent, Institut für Medizintechnik, Hochschule Luzern

Software Development According to IEC 62304 - A Real-World Perspective

 

Download slides here.

Presented by: Matthias Steck, Senior Consultant SW Development & Cyber Security, ISS AG

Hit by a laser – Risk Assessments Management at Ziemer Ophthalmic Systems AG

 

Download slides here.

Presented by: Reto Sigrist, Project Manager, Ziemer Ophthalmic Systems AG

Are we there yet? Using KPIs to track Technical File progression

 

Download slides here.

Presented by: Karl Larsson, Medical Device Documentation Expert, Aligned AG

Aligned Elements as Hosted Solution

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As of April 2020, we offer Aligned Elements as a Hosted solution as a complement to our existing deployment options. It is thus now possible to deploy the Aligned Elements server On-Premise, in your own Cloud, or have it hosted by us. 

The Hosted Solution will be a welcome option for our medical device manufacturing clients that do not have or are not in a position to engage, IT infrastructure and/or IT personnel.

We host your Aligned Elements database server, web application, and system integrations in the cloud on the reliable Microsoft Azure platform, applying your unique configuration of Aligned Elements, designed to match your QMS, development process, and document templates. 

Use your standard browser to access the Aligned Elements web client and allow your team to break free from technical considerations and focus on their medical device development. Automatic maintenance and monitoring are continuously performed by our experts.

As new versions of Aligned Elements are released, each client decides on when the new versions shall be deployed. A client's solution will only be updated upon explicit request in order to deliberately move from one validated application state to another. 

Register for "Sharpen Your Skills 2020" - Free Virtual Medical Device Development Seminar

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April 28th, 2020 | 09:00 - 12:15 | Free Virtual Seminar


Aligned Seminar

Compliant and Efficient Medical Device Development

An impossible combination? 

Join us to gather concrete and practical advice on how to meet trending medical device development challenges in 2020.

We have called on a group of experienced industry experts to share their latest best practices on how to eliminate problems with you.

Register now to reserve your seat!

We look forward to seeing you at this event. If you have any questions or information requests, please don't hesitate to This email address is being protected from spambots. You need JavaScript enabled to view it.

REGISTER NOW!


Key Learning Objectives

Perspective of Post-Market Surveillance under MDR

The Medical Device manufacturer’s effort put into Post Market Surveillance (PMS) is increasing drastically under the MDR regime.
The task in front of us appears daunting at best and overwhelming at worst.
Learn from our invited experts on how to collect enough PMS data to stay compliant and efficient at the same time.

Presented by: Linda Ahnen, PhD, Project Associate, Medidee

When to test what and why. A true story from a developer’s perspective. 

V&V activities are always planned last, that is why they have no right to fail, but from failure, we learn, how can we use testing to our advantage?
Based on the example of an implantable pump, we discuss what kind of verification can and should be done at which stage of development and how it should be documented.

Presented by: Dr. Thomas Degen, Dozent, Institut für Medizintechnik, Hochschule Luzern

Software Development According to IEC 62304 - A Real-World Perspective

It is said that 'No battle plan survives the contact with the enemy'. What is the best way to plan and implement IEC 62304 in an efficient and compliant manner?
Learn from the successes and failures of leading medical device manufacturers in Switzerland.

Presented by: Matthias Steck, Senior Consultant SW Development & Cyber Security, ISS AG

Hit by a laser – Risk Assessments Management at Ziemer Ophthalmic Systems AG

’Did you assess the risks correctly?’ When your device is a laser for eye surgery, this is a very valid question.
Find out more on how Ziemer Systems structures the risk management file; and integrates device data, post-market surveillance information, clinical data, and much more in a comprehensive risk assessment approach for a complex medical device.

Presented by: Reto Sigrist, Project Manager, Ziemer Ophthalmic Systems AG

Are we there yet? Using KPIs to track Technical File progression

Key Performance Indicators are widely used by organizations to evaluate their success at reaching critical targets. In the context of Medical Device Technical File documentation, what are examples of good and bad KPIs.
Learn from this session how Requirement Management, Risk Management, Test Management, and Document Management can be monitored using KPIs.

Presented by: Karl Larsson, Medical Device Documentation Expert, Aligned AG


Time and Place

  • Date: Tuesday, April 28th
  • Time: 09:00 - 12:15
  • Live Streamed from the Aligned HQ. Sign up to get your access link!

Presentations are held in German. Slides are written in English.

Target audience

This event is aimed at medical device development professionals, project managers, QARA professionals, R&D personnel, and other industry professionals engaged in medical device development.

Registration

Register to get your online access. We are looking forward to seeing you in this virtual seminar!

REGISTER NOW!


 

About Aligned AG

Aligned AG provides Aligned Elements, a Medical Device ALM system that accelerates and ensures compliant Design Control documentation for medical devices. We assist our clients in developing regulatory compliant products within shorter time-frames, to lower costs and with higher confidence. 

This event is a collaboration between Aligned AG and Health Tech Cluster Switzerland.

 HTCS

Accelerating the Conformity Assessment process

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Ripple effects of all sorts is felt on many levels throughout the industry due to the strained European MDR situation.

The bottom line is simply more work for everybody. As medical device players scramble to get compliant in time, the convoluted situation has ignited creativeness among digital solution providers. New propositions emerge on how to carry out the increased workload in the most efficient manner possible. We certainly try to be one of these providers but there are plenty of other exciting companies with fantastic ideas.

One such solution provider is MedtechVault in Switzerland, a company that launched its digitization product in 2019 to target some of the complexities that emerge out of MDR. We had the opportunity to meet with Mr. Arik Zucker, co-founder of MedtechVault, and got the chance to ask him more about MedtechVault.

Register for "Sharpen Your Skills 2019" - Medical Device Development in the MDR Era

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Sharpen your Skills 2019

May 21st, 2019 | HWZ University, 3 minutes from Zürich Main Station


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Compliant and Efficient Medical Device Development

An impossible combination? 

Join us to gather concrete and practical advice on how to meet trending medical device development challenges in 2019.

We have called upon a group of experienced industry experts to share their latest best practices on how to eliminate problems with you.

Register now to reserve your seat!

We look forward to seeing you at this event. If you have any questions or information requests, please don't hesitate to This email address is being protected from spambots. You need JavaScript enabled to view it.

REGISTER NOW!


Key Learning Objectives

The way to MDR: real-world experience

The MDR transition window is closing. Manufacturers, Notified Bodies, and Distributors are working vehemently to reach the opposite shore in one piece.
An excerpt of the experience of adapting to these new requirements, including hints and best practice are presented in this session.

Presented by: Hansjörg Riedwyl, CEO, ISS AG

Hidden cost drivers in clinical investigations - the importance of strategy

Market access and approval are more dependent than ever on clinical data. Getting your clinical trial design right, in time and within budget, is one of the most important steps.
This session focuses on the importance of collaboration with regulatory and clinical operations experts to minimize the risk for delays as well as costs.

Presented by: Carin Nilsson, Partner, Confinis CPM

Computer System Validation CSV – between ZERO and HERO

How to best handle the conflicting expectations from Management, IT, Quality Department, and (last but not least) the Auditor?
Gerhard Dariz provides deep, real-world insights from corporate practice and shows possible strategies to survive this area of tension.

Presented by: Gerhard Dariz, CEO, Inmedis GmbH

Clinical Evaluation and Post Market Clinical Follow-Up under MDR

MDR introduces important changes in expectations on how to demonstrate device safety and performance prior to market access.
This session provides an overview and hands-on examples of the Clinical Evaluation and Post-Market Clinical Follow-Up processes under the MDR.

Presented by: Dr. Autumn Lang, CEO, Confinis CPM

Automated Design Control Documentation

Machine Learning. Digitalization. The future holds a promise of machines performing more and more of our daily tasks. However, many of us are still putting Design Control Documentation together character by character. Can the Design Control Documentation be automated? What would that look like? What are the limitations?

Presented by: Karl Larsson, Medical Device Documentation Expert, Aligned AG


Time and Place

  • Date: Tuesday, May 21st
  • Time: 08:15 - 13:30
  • Place: HWZ University, Zürich

Presentations are held in German. Slides are written in English.

Target audience

This event is aimed at medical device development professionals, project managers, QARA professionals, R&D personnel, and other industry professionals engaged in medical device development.

Registration

We are looking forward to seeing you at this seminar!

Registration Fee: 125 CHF

30% early bird discount for registration before May 1st.

REGISTER NOW!


Location

Address: HWZ Hochschule für Wirtschaft Zürich, Lagerstrasse 5, Zürich

HWSMap

 

About Aligned AG

Aligned AG provides Aligned Elements, a Medical Device ALM system that accelerates and ensures compliant Design Control documentation for medical devices. We assist our clients in developing regulatory compliant products within shorter time-frames, to lower costs and with higher confidence. 

This event is a collaboration between Aligned AG and Health Tech Cluster Switzerland.

 HTCS

Register for "Sharpen Your Skills 2018" - Efficient Medical Device Development

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Sharpen your Skills 2018

May 17th, 2018 | HWZ University, 3 minutes from Zürich Main Station

Skills

Compliant and Efficient Medical Device Development

An impossible combination? 

Join us to gather concrete and practical advice on how to meet trending medical device development challenges in 2018.

We have called on a group of experienced industry experts to share their latest best practices on how to eliminate problems with you.

Register now to reserve your seat!

We look forward to seeing you at this event. If you have any questions or information requests, please don't hesitate to This email address is being protected from spambots. You need JavaScript enabled to view it.


Key Learning Objectives

Medical Device IT Security

Live hacking session, an introduction to the regulatory requirements and hands-on tips for developers of medical devices - by Prof. Dr. Christian Johner, CEO, Johner Institute

Implementing GDPR at Polar

Learn more about how Polar implemented one of the most important regulatory changes in 2018. If you haven't started yet, get the do's and don'ts from Niclas Granqvist, Director Apps & Electronics, Polar Electro Oy

Common Usability Engineering Pitfalls

What could possibly go wrong? Expected and unexpected outcomes from the usability engineering process based on real-life examples - by Andrea Schütz-Frikart, Human Factor Specialist, Frikart Engineering GmbH

Post-market surveillance, Transition from MDD to MDR

The lean and mean approach to performing MDR post-market surveillance using a realistic framework - by Stephanie Grassmann, MedTechXperts GmbH

Modular Design Control Documentation

Can Design Control Documentation be modularized and re-used in several Medical Devices? Discover the Pros and Cons - by Karl Larsson, Design Control Documentation Expert, Aligned AG

 


Time and Place

  • Date: Thursday, May 17th
  • Time: 08:15 - 13:00
  • Place: HWZ University, Zürich

Presentations are held in German. Slides are written in English.

Target audience

This event is aimed at medical device development professionals, project managers, QARA professionals, R&D personnel, and other industry professionals engaged in medical device development.

Registration

We are looking forward to seeing you at this seminar!

Registration Fee: 125 CHF

30% early bird discount for registration before May 1st.

 

 


Location

Address: HWZ Hochschule für Wirtschaft Zürich, Lagerstrasse 5, Zürich

 

HWSMap

 


About Aligned AG

Aligned AG provides Aligned Elements, a Medical Device ALM system that accelerates and ensures compliant Design Control documentation for medical devices. We assist our clients in developing regulatory compliant products within shorter time-frames, to lower costs and with higher confidence. 

What I learned at the Aligned Elements User Conference 2017

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Last week we met up with some of the Swiss Aligned Elements users at the Aligned Elements User Conference 2017. It was a very rewarding occasion for me and our team. For ten years, we have grown together with our customers and many of the best improvements we have done to Aligned Elements, are ideas from our customers.

It is not always about new features

It is easy to get locked into the thought process of adding new features as an ISV. However, this user gathering underlined how much "unlocked potential" lies in slightly tweaking existing features, features that might not look very impressive on the surface but still has an enormous impact on usability due to their frequent use. For us, it was a real eye-opener to hear about the large impact of two small features called "Reset Format" and "Paste as Plain Text". The participants had some good suggestions for improvements that we certainly will implement for the next service pack.

Different Users have different needs

As the discussion went on, it became clear that the needs of the groups "Frequent Users", "Infrequent Users" and "Administrators" are quite different. Whereas the Administrator representatives requested better support for User Management and changes made over large Project sets, the Infrequent Users were in greater need of clearer work instructions and an interface adapted to their specific tasks. One user compared Aligned Elements with Photoshop, "if you are a power user, Aligned Elements is extremely powerful, but if you only log in every six months to tick of tasks assigned to you, the interface is intimidating and do not do much to guide this user." We have great ideas in this area that we hope to be able to include in our next version.

Follow that document

Several users pointed out that Document Management, Review, Release, and Sign-off actions have the potential for improvements, both in scope and implementation details. This is something we are aware of and the user feedback delivered during the conference was very helpful on these points.

We are grateful to the participants for having joined this year's User Conference and will do our best to incorporate the improvements and suggestions in future Aligned Elements releases.

Cybersecurity, pacemakers and recalls

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Cybersecurity issues resulted in 465 000 St Jude pacemakers being subjected to an FDA recall due to fears of exploiting existing cybersecurity vulnerabilities in the device. A security hole exposes the device to hacking risks, potentially resulting in running the batteries down or even alter the patient’s heartbeat.

pacemaker

Although the risk is extremely low, the cost for St Jude / Abbott is significant. For a smaller firm, these ramifications can be detrimental. The long lifetime of medical devices and an ever-evolving cybersecurity arena makes devices vulnerable to cyber risks. Handling them effectively will be a significant challenge for the industry in the years to come.

We are addressing Cybersecurity Issues in the Supply Chain during a Keynote at the Swiss Medtech Expo in Luzern, 19-20 September.

Join us for this key note or come and meet us at the Expo at Booth B2045, Halle 02.

Aligned at Swiss Medtech Expo, Lucern 19-20 September

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Aligned will present at the Swiss Medtech Expo in Lucern from 19-20 September!

Come and meet us at the Expo at Booth B2045, Halle 02 and discover the possibilities you have to reduce time and money spent on Design Control Documentation.

Let us explain to you the idea behind the Aligned Elements and how other medical device manufacturers have saved up to 60% of their documentation maintenance effort. 

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To get your free ticket, click here: Free Entry Ticket Swiss Med Tech Expo

Find more information about the Expo here.

 

 

Questions about MedTech standards? Get the answers straight from the source!

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Our friends at Qadvis have grown steadily over the last couple of years and this is no wonder.

qadvislogo

These guys are co-authors of many of the standards you use today. If you have questions about ISO 13485, IEC 62304, IEC 80001-1, or IEC 60601-1, who would be better to ask than the person who actually penned it? 

I can highly recommend their services and advice. Just recently the Qadvis Team put together a ton of Quality and Regulatory material for download on their website. For free!

Go take a look!

 

Meet us at Med Conf 2016 in München 25-28 October

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We are participating in the Med Conf 2016 25-28 October with our lecture "Death by Documentation - how to identify documentation inefficiencies in your medical device development process"

If you are interested in how to assess the documentation process in order to find process inefficiencies in your own company, then this one is for you!

The lecture is held by our CEO Anders Emmerich on 27. October at 14:10.

Find the complete agenda here.

If you want to meet us during the conference, please This email address is being protected from spambots. You need JavaScript enabled to view it. and we'll set up an appointment!

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Announcing the 2016 Medical Device Documentation Survey!

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The 2016 "Documentation Trends and Insights in Medical Device Documentation" survey is live!

Are you alone in experiencing challenges when it comes to Medical Device Documentation? Or is what you feel shared by the industry?

Man with papers

We invite you as a Medical Device professional to share your thoughts on the state of documentation practices by participating in this survey.

The survey will assess how Medical Device organisations manage regulatory driven documentation challenges during the R&D phase.

Take the 2016 Medical Device Documentation Survey now!

EU agreement on new medical device rules as Switzerland "Sharpens the Skills!"

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On 25 May 2016, the same day as the EU agreed new rules on medical devices and in vitro diagnostic medical devices, the seminar "Medical Device Development - Sharpen your Skills!" was held at the sold-out event venue Marriott Courtyard in Zürich.

sharpen

The theme of the seminar "Medical Device Development in a dynamic regulatory landscape" was scrutinized in depth by Mario Gennari, Gemar SRL, former TüV auditor and special-guest brought in by the Prismond Group, who stressed the importance of undertaking a combined, timely gap analysis of the new EU regulations as well as the updated ISO 13485:2016 in order to understand, plan and execute the necessary step to comply to the new regulatory requirements. The talk was followed by a lively discussion on how to best solve practical issues entailing these regulatory changes.

Mr. Christian Steiner, from Thoratec Switzerland GmbH shared insights and lessons learned from a recent risk management audit, how to deal with potential findings, and elaborated on best practices when undertaking risk management improvements while optimizing limited resources.

Finally, the Aligned Team presented an analysis on medical device documentation aspects, the drivers behind excessive documentation work and possible solutions around it, concluding that large potential improvements can be made through tight collaboration and feedback between the party that design processes and templates and the party being required to use and fill these artefacts with content.

If you are interested in the presentations, please This email address is being protected from spambots. You need JavaScript enabled to view it..

We are looking forward to see you at the next seminar!