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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

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.

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!

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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 This email address is being protected from spambots. You need JavaScript enabled to view it.. 

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

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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 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.

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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

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 

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!

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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

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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 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.