Common Medical Device QMS Audit Problems and How to Deal with Them

We often perform audits and wonder why, when they're complete, they didn't go very well. This article will offer insight on how to better anticipate and solve the common problems that all auditors face, and some solutions on how to deal with them constructively.

About the author
Richard A. Vincins is a Certified Quality Auditor and regulatory affairs consultant with Emergo Group. He is responsible for the implementation of quality systems, conducting internal audits, training on quality system tools, and providing regulatory expertise in national and international regulations. Vincins has more than 20 years of experience in the medical device industry, including worldwide regulatory compliance efforts for in vitro device, medical device, and pharmaceutical companies.