20. August 2025
Cybersecurity for connected medical devices: meet MDR, NIS2 & FDA requirements, minimize risks, and protect patient safety in 2025.
20. August 2024
AI has the potential to revolutionize healthcare and improve the lives of millions of people - but only if it is used safely and reliably.
19. August 2024
Common Criteria (CC): International IT security standards for medical devices, supported by BSI and BfArM, enhance cybersecurity and trust in processes.
29. July 2024
Digital progress does not stop at medical devices. Read here how you can protect yourself, your product and your software.
21. December 2022
Areas: Europe, Worldwide / Updates, New regulations and guidances 51/22
5. August 2022
Which clinical strategy do I use to evaluate my software as a medical device according to MDCG 2020-1? We know the regulatory requirements.
21. July 2022
Life Cycle management tool support in medical technology. DOORS, RQM or ELM - correctly manage requirements, tests, documentation and traceability.