Thursday October 27th, 2022 | 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: 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 Diese E-Mail-Adresse ist vor Spambots geschützt! Zur Anzeige muss JavaScript eingeschaltet sein.. 

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.

Tuesday May 9th, 2023 | 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: 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 Diese E-Mail-Adresse ist vor Spambots geschützt! Zur Anzeige muss JavaScript eingeschaltet sein.. 

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.

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.

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.  

Register to the seminar "Sharpen your Skills! - Medical Device Development 2016 in a dynamic regulatory context"

Take this opportunity and find out how to rapidly deliver innovative medical devices as the regulatory landscape is changing.

Key learning objectives:

• New EU MD Regulation & ISO 13485:2016 - Assess and adapt, change and comply
• Design Control Best Practices - common mistakes and lessons learned from real project cases
• Death by documentation - innovate or administrate? Uncover documentation inefficiencies in your DHF process
• Risk Management when the heart stops - An ISO 14971 Case Study from a Class IIb product

Register now to reserve your seat!

Our event is aimed at medical device development professionals, project managers, QARA professionals, software managers and architects, designers and developers, and other personnel engaged in medical device development. We are at this seminar dealing with the fundamental question of medical device development: how to rapidly develop and deliver innovative medical devices while ensuring compliance.

Take the opportunity to sharpen your medical device development skills and update your knowledge at our half-day seminar on the existing and upcoming challenges in today's dynamic regulatory environment.

Register now to reserve your seat!

When: Wednesday, May 25th, 08:30 - 13:00

Where: Hotel Marriott Courtyard Oerlikon, Zurich (directions)

Price: 125 CHF  (Note! 30% early bird discount for registrations before May 1st)

Presented by: 

• Mario Gennari, Regulatory Affairs and Design Control Expert, Prismond Group AG, former Lead Auditor at TÜV SÜD
• Christian Steiner, Quality Assurance Manager, Thoratec Switzerland GmbH
• Anders Emmerich, CEO, Aligned AG

Hosted by: Prismond Group AG / Aligned AG

For any questions, please feel free to Diese E-Mail-Adresse ist vor Spambots geschützt! Zur Anzeige muss JavaScript eingeschaltet sein..