• Written by

• on

• . Posted in

How to efficiently develop Medical Devices for compliance

Register today to reserve your seat!

Sign Up!

Key Learning Objectives

14:30 - 15:00 From Compliance to Risk: Rethinking Medical Software Testing

15:00 - 15:30 Decoding Essential Performance in IEC 60601-1: The Hidden Difference That Could Make or Break Your Medical Device

15:30-16:00 Testing the untestable: Computer Software Validation of AI functionality

16:00 - 16:30 The interconnected eQMS: Addressing (and eliminating?) 'The work around eQMS work'

Register today to reserve your seat!

Sign Up!

{fastsocialshare}

Thank you very much for joining us for this Sharpen your Skills 2025 Part 2 session!

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

Session Recordings

When ‘Guidance’ Isn’t a Suggestion: Hard Truths on FDA Software & Cybersecurity Compliance

Presented by: Paul Gardner, Head of Development, Ypsomed Selfcare Solutions

Efficient design control in risk management: an FDA audit meets database logic

Presented by: Udo Warschewske, COO, Senior Consultant, MBA, Tecurat

From Algorithms to Authorisations - Demystifying AI/ML Device Approval

Presented by: Richie Christian, Senior Medical Device Consultant, Wega Informatic AG

Efficiency Through Reuse: Eliminating Duplication in Design Controls

Presented by: Anders Emmerich, CEO, Co-Founder Aligned AG

• Written by

• on

• . Posted in

How to efficiently develop Medical Devices for compliance

Register today to reserve your seat!

Sign Up!

Key Learning Objectives

When ‘Guidance’ Isn’t a Suggestion: Hard Truths on FDA Software & Cybersecurity Compliance

Efficient design control in risk management: an FDA audit meets database logic

From Algorithms to Authorisations - Demystifying AI/ML Device Approval

Efficiency Through Reuse: Eliminating Duplication in Design Controls

Register today to reserve your seat!

Sign Up!

{fastsocialshare}

Thank you very much for joining us for this Sharpen your Skills 2025 session!

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

Session Recordings

Adapting Your Regulatory Strategy Amid U.S. and FDA Instability

Presented by: Jurjen Zoethout, Senior Partner, Lucendra MedTech Consulting

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

Presented by: Martin Schroeder, Senior Risk Manager, KARL STORZ SE & Co. KG

Practical post-market surveillance under the MDR/IVDR

Presented by: Camilla Messerli, Head Quality Management & Regulatory Affairs, Effectum Medical AG

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

Presented by: Karl Larsson, Managing Director, Aligned AG

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.

Download Certificate

• Written by

• on

• . Posted in

How to efficiently develop Medical Devices for compliance

Register today to reserve your seat!

Sign Up!

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

Register today to reserve your seat!

Sign Up!

{fastsocialshare}

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

 {fastsocialshare}

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

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)

{fastsocialshare}

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)