As a Senior Contributor to InCompliance, many years I am asked to update my articles to be placed in the Annual Guide but rarely do 2 of my articles show up in the Guide in a year. This year 2
InCompliance Annual Guide Articles
MDCG March ’20 Meeting – Industry & Notified Bodies Provide Feedback
The Medical Device Coordination Group (MDCG) is meeting on March 11 & 12th to hold a series of meetings. Part of these meetings includes hearing feedback from industry and Notified Bodies on stakeholder preparedness for the application of the MDR
Faces in Compliance
As a Senior Contributor to InCompliance Magazine, I have been fortunate to been asked to be part of this special supplement where InCompliance Magazine is featuring people that have been involved in Medical Device Compliance and Standards Development for a
MDR / IVDR Designation 2019 Stats
EU Commission promised 20 Designations 12 Notified Bodies Designated to MDR (9) & IVDR (3*) *All 3 IVDR Notified Bodies have MDR designation as well, so that can be counted as double counting. It depends on your perspective. 2 NB’s
The Future of the IEC 60601 Series: An Update
Read the article I wrote for InCompliance Magazine recently. I just got back from China at the end of Oct 2019 where I was at IEC meetings for 2 weeks working on IEC 60601-1, edition 3.2 and it’s collaterals and