20. June 2023
Areas: Europe, Worldwide / Updates, New regulations and guidances 25/23
News
13. April 2023
Areas: Europe, Worldwide / Updates, New regulations and guidances 15/23
4. April 2023
In China, Post Market Surveillance (PMS) is an important component of the regulation for medical devices, ensuring the safety and effectiveness of these products.
31. January 2023
Areas: Europe, Worldwide / Updates, New regulations and guidances 05/23
21. December 2022
Areas: Europe, Worldwide / Updates, New regulations and guidances 51/22
10. November 2022
Areas: Europe, Worldwide / Updates, New regulations and guidances 45/22
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.
1. August 2022
Areas: Europe, Worldwide / Updates, New regulations and guidances 31/22
21. July 2022
Life Cycle management tool support in medical technology. DOORS, RQM or ELM - correctly manage requirements, tests, documentation and traceability.
24. May 2022
Areas: Europe, Worldwide / Updates, New regulations and guidances 20/22
16. May 2022
Medical devices are often highly complex products made of different materials. About the handling of different substances.
25. April 2022
Areas: Europe, Great Britan, Taiwan, Australia and USA / Updates, New regulations and guidances 15/22
