We are thrilled to announce that, as of October 2024, Aligned AG is officially ISO/IEC 27001:2022 certified.

Commitment to Excellence in Information Security

This internationally recognized standard for information security management systems (ISMS) demonstrates our commitment to protecting the confidentiality, integrity, and availability of information, data, and systems against unauthorized access.

Earning this certification highlights our proactive approach to managing risks and vulnerabilities, ensuring they are identified and addressed before they escalate. By complying with the highest standards for information security, we continue to uphold operational excellence and reinforce trust with our clients and partners.

A Milestone for Aligned AG

The certification process was rigorous, involving a detailed audit and thorough evaluation conducted by SQS. This achievement is a testament to the strength of our ISMS and the dedication of our team to maintaining a robust security framework. Furthermore, we remain committed to ongoing excellence by conducting regular internal and external audits to ensure continuous compliance with ISO/IEC 27001 standards.

“Achieving ISO/IEC 27001:2022 certification marks a significant milestone for Aligned AG. This certification underscores our unwavering commitment to safeguarding the information and trust of our clients. It reflects the dedication of our team to maintaining the highest standards of information security, enabling us to provide innovative and relevant solutions with the utmost integrity." - concludes Anders Emmerich, CEO of Aligned AG and continues: "We are proud to continue supporting our medical device customers and partners with enhanced confidence in our secure practices."

We look forward to continuing to deliver secure, reliable, and innovative solutions to our valued clients, with the assurance that their information is protected by world-class security standards.

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How to efficiently develop Medical Devices for compliance

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Key Learning Objectives

Navigating Uncertainty:
Adapting Your Regulatory Strategy Amid U.S. and FDA Instability

Managing non-redundant work items within the digital thread:
An example of a Risk Management System at Karl Storz

Practical post-market surveillance under the MDR/IVDR

Digital Usability Engineering and Risk Assessments:
Practical examples using a Medical Device ALM

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Thank you very much for joining us for this Sharpen your Skills 2024 session!

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

Session Recordings

Decoding IVDR: Simplifying Software Classification for In Vitro Diagnostics

Presented by: Dr. Anca-Sarmiza Gültekin-Tigan, Senior Consultant, Quaregia GmbH

Verification & Validation Plan – The most boring or the most important document?

Presented by: Thomas Bohnen, CEO, Keymkr GmbH

Product Requirements – How to keep them manageable and maintainable

Presented by: Dr. Ivo Locher, Program Manager, Konplan AG

Hazard Analysis vs FMEA vs Cyber Security Risks – Examine similarities and differences

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

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Tuesday Oct 22nd, 2024 | 13:30 - 16:30 CET | Free Online Medical Device Development 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.

Register now to reserve your seat!

Register on Linked In: Click here

We look forward to seeing you at this event. If you have any questions or information requests, please don't hesitate to Diese E-Mail-Adresse ist vor Spambots geschützt! Zur Anzeige muss JavaScript eingeschaltet sein.. 

Key Learning Objectives

Decoding IVDR: Simplifying Software Classification for In Vitro Diagnostics

This talk provides key insights into the classification of medical device software under the IVDR, with a focus on standalone software, software with multiple functionalities, and interactions with devices classified under different risk categories.

Through real-world examples, participants will gain practical skills for applying IVDR rules to various software scenarios, including strategies for managing software updates and post-market compliance.

The session will address challenges posed by AI/ML-based software, exploring overlaps with the AI Act and how to maintain compliance in a rapidly changing environment. 

Presented by: Dr. Anca-Sarmiza Gültekin-Tigan, Senior Consultant, Quaregia GmbH

Verification & Validation Plan – The most boring or the most important document?

Standards and regulations say that verification and validation of a medical device is a) required and b) needs to be planned. So far, nothing new.

But is V&V planning just a regulatory exercise, or could it contribute to the project effectively?

The talk will show that the V&V plan is the single most important document for the project manager. It defines critical aspects about time and budgets and helps steering the project’s progress. It becomes the project managers “GPS”, showing where he stands. And how long the rest of the way is.

Presented by: Thomas Bohnen, CEO, Keymkr GmbH

Product Requirements – How to keep them manageable and maintainable

In the world of medical device development, crafting clear and effective Design Requirements is an essential, yet often overlooked skill.

Learn through Dr. Lochers analysis of the unseaming consequences of poor writing style and tap into his  easy-to-use rules that immediately will improve your requirement writing skills.

In this presentation, Dr. Ivo Locher will share practical insights from years of industry experience, highlighting key best practices that distinguish good requirements from bad.

Presented by: Dr. Ivo Locher, Program Manager, Konplan AG

Design Risks vs FMEA vs Cyber Security Risks – Examine similarities and differences

Risk Management is central to medical device development and manufacturing. From a past, strong reliance on FMEA only, today's risk assessment methods are richer and more rewarding.

In this talk, we’ll compare and contrast different risk assessment types to unveil their differences and commonalities in order to get the most out of each and every type. We’ll also present some data on how real-world medical device manufacturers have chosen to apply different risk assessment methods.

Presented by: Karl Larsson, Managing Director, Aligned AG

Time and Place

• Date: Tuesday, Oct 22nd
• 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.  

Within recent years, Human Factors and Usability Engineering in Medical Devices have evolved to become a mandatory design input requirement for the development from medical products worldwide.

As patient care evolves and is transferred to private homes or public environments, less skilled or even unskilled users including patients and caretakers must be enabled to safely use these complex devices. The academic field of Human Factors Engineering is represented at many institutions. University of Furtwangen is one of them, offering a master's degree in Human Factors, focusing on all aspects that lead to human-centered technology and optimal human-machine interaction.

Humans at the center, Experts in the making

To prepare the students for the future, the University of Furtwangen has decided to incorporate digital tools in their education and uses Aligned Elements to create, trace and manage Usability and Human Factors related Design Control as well as embedding these in the overall traceability and medical device development documentation.

"Performing and documenting the intertwined domains of usability engineering, risk management and requirements management according to Medical Device regulations and standards, such as the IEC 62366, is required in medical device development and poses particular challenges to engineers and manufacturers. Aligned Elements has proved to be the ideal software for us to convey this aspect of medical device development to our students."

"In order to work through the regulatory requirements for the development process, using a holistic example, we include a practical exercise entitled Design Control alongside the lectures", says Prof. Dr.-Ing. Stefan Pfeffer, Dean of this Human Factors course.

Hands-on work with real-world examples

The students work with Aligned Elements and think through the process using the example of a blood pressure monitor.
The great thing about this is that, by developing the content in Aligned Elements, the students will also experience how the three processes are interconnected and how synergies between them are created.

"We believe that this approach is the optimal way to prepare our students for the challenges and realities in modern medical device development.", concludes Prof. Dr.-Ing. Pfeffer.

How Aligned supports Furtwangen University

"The increased focus on Human Factors Engineering is one of the most patient-relevant shifts in our industry in recent years. It is an aspect that has been treated as an afterthought far too long. That "anyone with a bit of taste" can conduct meaningful and value-creating usability engineering is simply not true. Experts are dearly needed and we are happy to support the University of Furtwangen in this endeavour, to equip the next generation of experts with the skills they need to successfully develop the next generation of medical devices.", adds Karl Larsson, Managing Director, Aligned AG

Find out more at: Human Factors - Become a human-machine interpreter (hs-furtwangen.de)

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Professor Mike Fornefett aims to prepare his students for the workforce by teaching modern software tools and processes through a hands-on approach. Before joining the University of Furtwangen, Prof. Fornefett spent over a decade with hands-on medical device development.

His graduates leave the master’s program well-prepared to tackle real-world medical device development challenges using state-of-the-art technology.

As part of this modern approach to medical device engineering, Prof. Fornefett instructs his students on using Aligned Elements as an example of a modern software tool for Design Control Management and Technical Documentation.

Moreover, he tracks the progress of his students' work using the same software.

Medical Devices - Regulatory Affairs Master: A Degree for the Future

To address the medical device industry’s rapidly increasing demand for highly trained professionals, this program focuses on the approval of medical technology products, process and quality management, and development processes in the field of medical devices. This master's degree can be completed in five semesters while working.

Tackling Medical Device Development Challenges Hands-On

After studying several in-depth modules covering both regulatory and development aspects of medical device development, students can focus on IT tools in regulatory affairs. Here, they solve practical tasks using the application lifecycle management tool Aligned Elements. By addressing design controls throughout the product lifecycle and by managing regulatory documents, students gain comprehensive familiarity with the complexity and interdependencies of medical device development documentation, as well as the strategies and tools available to streamline these tasks.

 “When it comes to training, it is important to our team that we teach the legal and normative principles, but also methods of how something can be implemented, for example risk management for medical devices.

The third pillar is practice, in which we look at the implementation using various IT tools together with the students and also practice some of them. We are grateful to Aligned for their support here.”, says Professor Fornefett.

 How Aligned supports Furtwangen University

"Ensuring that medical device professionals are thoroughly trained in both regulations and state-of-the-art tools is paramount to advancing healthcare and patient safety. We are thrilled to support the University of Furtwangen in this endeavour, to equip the next generation of experts with the skills they need to successfully develop the next generation of medical devices.", adds Karl Larsson, Managing Director, Aligned AG

Find out more at: Expertise in the approval of medical products (hs-furtwangen.de)

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Thank you very much for joining us for this Sharpen your Skills session!

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

Session Recordings

Agile and SaMD development – pitfalls to avoid!

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

Tales of Tangles and Triumphs: Navigating the Pitfalls of Medical Device Development

Presented by: Pierfelice Ciancia, Business and Systems Engineering Consultant, Ciancia Consulting Partners

Around the globe – Med Tech Usability evaluations in an international context

Presented by: Dr. Benedikt Janny, Head of Usability Engineering at USE-Ing. GmbH

7 reasons why Risk Assessments are horrible - and how to tackle them

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

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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

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Monday May 27th, 2024 | 13:30 - 16:30 CET | Free Online Medical Device Development 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: Click here

We look forward to seeing you at this event. If you have any questions or information requests, please don't hesitate to Diese E-Mail-Adresse ist vor Spambots geschützt! Zur Anzeige muss JavaScript eingeschaltet sein.. 

Key Learning Objectives

Agile and SaMD development – pitfalls to avoid!

Many organisations fail to fully utilise Agile methodologies while developing SaMD products.

This talk will discuss the "dos and don'ts" of using Agile for medical device software development.
Agile can improve design control and save time and resources when used correctly.

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

Tales of Tangles and Triumphs: Navigating the Pitfalls of Medical Device Development

In this talk, we'll explore the importance of adaptable business requirements, demonstrated by a diagnostic device project, where not anticipating market evolution results in dramatic consequences.

We'll delve into the cautionary tale of a failed Model-Based Systems Engineering (MBSE) implementation, hindered by over-reliance on a complex modelling language known only to a 'chosen one,' spotlighting the critical need for accessible and common understanding in project teams.
Highlighting a project ensnared in an extended testing phase due to initially untestable requirements, I'll share insights into the pivotal role of early-stage validation to prevent costly delays and ensure a smooth path to market approval.

By: Pierfelice Ciancia, Business and Systems Engineering Consultant, Ciancia Consulting Partners

Around the globe – Med Tech Usability evaluations in an international context

The regional regulation and definition of standards to be complied with is constantly increasing, also in the field of medical usability engineering.
The latest publication of the Human Factors guidance of the Chinese NMPA illustrates this trend.

In this knowledge infusion, Dr. Benedikt Janny, compares existing international guidelines and elaborates how to validate when addressing different international markets.

By: Dr. Benedikt Janny, Head of Usability Engineering at USE-Ing. GmbH,

7 reasons why Risk Assessments are horrible - and how to tackle them

Risk Assessment can be terrible! They can be ambiguous, exhausting and leave you both drained and frustrated.
Remaining is that uneasy feeling, not knowing if you have gone deep enough and whether what you have entered makes sense to anyone else than yourself.
In this seminar, I  will share how I learned to stop worrying and love (well, not quite!) Risk Assessments.

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

Time and Place

• Date: Monday, May 27th
• 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.

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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