11. May 2023
Which regulations and guidelines apply to materials of animal origin and the risk assessment of zoonoses? We will tell you in part 2 of our series of articles.
News
4. May 2023
Many problems lurk when collecting clinical data as part of the PMCF. We help you to create a sensible strategy.
28. April 2023
Medical devices whose components include materials of biological origin require special risk management. In the first part of our series of articles on “Zoonoses”, we tell you how to meet the requirements of the MDR.
13. April 2023
Areas: Europe, Worldwide / Updates, New regulations and guidances 15/23
11. April 2023
Post-market surveillance for medical devices as an efficient process for practicability and added value.
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.