9. July 2020
Areas: MDR, COVID-19, USA, Russia, Malaysia, Updates, New regulations and guidances "Issue" 28/20
News
12. June 2020
Areas: MDR, COVID-19, Canada, Malaysia, UK, Updates, New regulations and guidances "Issue" 24/20
23. May 2020
Areas: MDR, COVID-19, Singapore, USA, Russia, Kazakhstan, Brazil, Canada, Malaysia, China, Updates, New regulations and guidances "Issue" 21/20
8. May 2020
Areas: MDR, FDA, COVID-19, Japan, Taiwan, Malaysia, Updates, New regulations and guidances "Issue" 19/20
24. April 2020
Areas: MDR, COVID-19, IMDRF, Updates, New regulations and guidances "Issue" 17/20
14. April 2020
Areas: MDR, COVID-19, Further EU / MDCG Updates, China, Canada, Updates, New regulations and guidances "Issue" 16/20
26. August 2019
MDR - as of May 26, 2020, a second reporting channel for the disclosure of "non-serious events" or "expected adverse reactions" will be added for all companies.
28. May 2019
Software testing ensures quality and makes development efficient. Intelligent automation is key to better software and higher customer satisfaction.
26. February 2018
For each medical device, clarify exactly which role and thus obligations you have as an economic operator! We will help you with this.
1. February 2018
We explain: How big and far-reaching are actually the changes in the classification of medical devices?
1. February 2018
We explain what a complete, correct classification according to MDR means and help you avoid typical mistakes.
1. February 2018
Overview of the most important changes and tips on where to look if you are unsure about the classification.