Regulatory & Safety Experts for Global Medical Device Approvals
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
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
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
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
Leo Eisner, the “IEC 60601 Guy”, will be presenting a session at MD&M West on Wednesday, Feb. 6, 2019 from 3:15 – 5:30PM Topic: Why Your Regulatory Strategy Can’t Ignore Medical Electrical Standards & Guidances Track: MD&M West: Regulatory & Quality
