EU: How to master a MDR challenge – experts in the LSN Magazine

In the newest article in the LSN– Life Science Nord Magazine you can read about how established medical technology companies, start-ups and regulatory experts in the North succeed in dealing with the new requirements of the EU Medical Device Regulation – even in times of uncertainty and  pandemic. Our Managing Director, Klaus-Dieter Ziel, shares experience from the Notified Body’s perspective.

You can read this article here: How to master the MDR-challenge.

Other topics:

• ATTENTION: fake certificates
• EU: New MDCG document Q&A on custom-made devices
• EU: New MDCG Documents on Clinical investigation
• EU: EUDAMED – new documents from the European Commission and MDCG
• EU: Is your software a medical device? An infographic
• EU: How to master a MDR challenge – experts in the LSN Magazine
• EU: MDR Initial Conformity Assessment Process as a Chart
• EU: UDI – Helpdesk and a new MDCG Guidance