User:Red66climb

Hi

I am a full-time regulatory consultant helping companies with regulatory submissions for high-risk medical devices, in vitro diagnostics (IVD) and drug/device combination products. My specialty is Design Dossiers for CE Marking.

My Quality Management System consulting covers all aspects of the EN ISO 13485:2012 Standard and 21 CFR 820 (the FDA QSR).

I contribute to articles related to this fields.