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.
News
19. August 2024
Common Criteria (CC): International IT security standards for medical devices, supported by BSI and BfArM, enhance cybersecurity and trust in processes.
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.