A Guide to Medical Device Corrective Action and Preventative Action (CAPA)

Time and time again the one process that nearly always presents the most challenges to medical device companies, regardless of shape and size, is Corrective Action & Preventive Action (CAPA). This article explores those challenges and provides the reader with best practices and ways to improve the CAPA process and approach.

New CCC Marking Regulations in China

China is the second biggest economy in the world. The strong economic growth of the last decades has lead the country to develop its own quality standardization system. The China Compulsory Certification (CCC) is a system which is comparable, but not identical in terms of standards and requirements to the EU’s CE mark or the FCC’s declaration of conformity in the U.S.

Banana Skins – June 2018 (#62-67)

We are pleased to bring you Banana Skins, a new monthly column in In Compliance, and a 20-year tradition that began in the pages of the EMC Journal. We hope you enjoy the column and look forward to continuing the tradition of sharing these valuable stories.