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).
News
9. December 2021
Assembled medical devices are referred to as systems and procedure packs under the MDR. Separate regulatory requirements of Regulation EU 2017/745 apply to these.
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
12. July 2021
As a partner in medical technology, our experts will assume the function of an external responsible person for your company if required.
16. June 2021
Areas: Europe, Australia, USA / Updates, New regulations and guidances 24/21
2. June 2021
Areas: Europe, Taiwan, Australia, Singapore / Updates, New regulations and guidances 22/21
11. May 2021
Areas: Europe, India, Singapore, Taiwan / Updates, New regulations and guidances 19/21