12. July 2021Person Responsible – Implementation of Article 15 MDRAs a partner in medical technology, our experts will assume the function of an external responsible person for your company if required.
16. June 2021Regulatory Affairs Update 24/21Areas: Europe, Australia, USA / Updates, New regulations and guidances 24/21
2. June 2021Regulatory Affairs Update 22/21Areas: Europe, Taiwan, Australia, Singapore / Updates, New regulations and guidances 22/21
11. May 2021Regulatory Affairs Update 19/21Areas: Europe, India, Singapore, Taiwan / Updates, New regulations and guidances 19/21
23. April 2021Regulatory Affairs Updates 16/21Areas: Europe, USA, Australia, Malaysia, / Updates, New regulations and guidances 16/21
1. April 2021Regulatory Affairs Updates 13/21Areas: Europe , MDCG updates, COVID-19, IMDRF, USA, Updates, New regulations and guidances "Issue" 13/21
30. March 2021Risk classes in the IVDRThe date of application of the IVDR is approaching. But which class does your product now belong to with the new regulation? We have summarized everything together that you need to know.
26. February 2021Regulatory Affairs Updates 09/21Areas: Europe, COVID-19, IMDRF, Asia, Myanmar, Australia, Russia, Singapore, Updates, New regulations and guidances "Issue" 09/21
8. February 2021Regulatory Affairs Updates 06/21Areas: COVID-19, Australia, Japan, Singapore, AHWP, Updates, New regulations and guidances "Issue" 06/21
25. January 2021Regulatory Affairs Updates 04/21Areas: Europe, COVID-19, USA, Australia, Canada, Malaysia, Updates, New regulations and guidances "Issue" 04/21
14. December 2020Regulatory Affairs Updates 51/20Areas: Europe, COVID-19, U.S. FDA, Australia, China, South Korea, Updates, New regulations and guidances "Issue" 51/20
23. November 2020Regulatory Affairs Updates 48/20Areas: Europe, U.S. FDA, Hong Kong, Australia, Updates, New regulations and guidances "Issue" 48/20