25. April 2022
The AET is an essential component for the biological safety assessment of the chemical characterisation of leachable substances in medical devices. Read details about the AET here.
News
1. April 2022
Qtec Spotlight is our focus on current topics from the medical device life cycle. Every quarter, our experts shed light on a specific area.
25. March 2022
Relevant aspects of biocompatibility of the essential safety and performance requirements for medical devices from Annex I of the MDR.
16. March 2022
Areas: Europe, Great Britan, Taiwan, Australia and USA / Updates, New regulations and guidances 11/22
11. February 2022
Areas: Europe, Great Britan, Taiwan, Australia and USA / Updates, New regulations and guidances 06/22
22. December 2021
Very few manufacturers and artists are aware that some of these products fall under the new Medical Device Regulation EU 2017/745 (MDR).
28. October 2021
We will show you why a quality assurance agreement is an important and central document of the MDR, and should make sure it is always up to date.
20. October 2021
Areas: Europe, USA, Australia / Updates, New regulations and guidances 42/21
6. October 2021
Areas: USA, Australia, Singapore, India / Updates, New regulations and guidances 40/21
7. September 2021
Areas: Europe, USA, Australia, India, Taiwan / Updates, New regulations and guidances 35/21
11. August 2021
Areas: Europe, Worldwide, Myanmar, Indian, Australia, Singapore, Canada, China / Updates, New regulations and guidances 32/21
15. July 2021
Areas: Europe, USA / Updates, New regulations and guidances 28/21
