Risk Management in Software Medical Devices: What Can Go Wrong?

What are the most common risk management mistakes we see in software medical devices? This presentation takes a practical look at recurring pitfalls identified during notified body assessments, with examples of where manufacturers often struggle – from identifying software-specific hazards to implementing and verifying effective risk controls.

Three Takeaways

• Identify the most common risk management pitfalls in software medical devices.
• Understand what notified bodies look for when assessing risk management documentation.
• Learn practical ways to strengthen risk identification, control, and verification.

Speakers

• Christian Jensen, Product Reviewer, TÜV SÜD

Agenda

11:45 Welcoming and lunch

12:00 Knowledge sharing presentation and Q&A

13:00 Mingling with coffee

Meet TÜV SÜD team

TÜV SÜD will also host an Open Desk on 8 December, between 08:00 and 16:30, offering the opportunity to discuss questions directly with the TÜV SÜD team.

Book your preferred time slot here.

About TÜV SÜD

TÜV SÜD about itself: TÜV SÜD Medical Health Services provides testing, certification and regulatory expertise services to MedTech companies throughout the medical device lifecycle, with global laboratories and 30+ years of experience, we enable manufacturers to demonstrate compliance with applicable regulatory requirements and optimized access to global markets, TÜV SÜD’s testing and certification services are independent of each other and delivered by separate testing laboratories and certification bodies.

Science for Lunch is a business meeting concept where event hosts showcase their offerings and/or share academic life science research with companies, employees, and visitors at Medicon Village. If you are interested in hosting a Science for Lunch event, or learning more about our other signature event concepts, please contact dimitra.manou@mediconvillage.se.