Year: 2020

CAPA Initiation – Containment & Correction Actions

By Shant Youkhana, Director of Quality and Strategic Solutions The Corrective and Preventative Action (CAPA) system is a regulatory requirement to which all Medical Device, Pharmaceutical, and Combination Product manufacturers must comply. Although there are minor differences between the CAPA system requirements in the Medical Device and Pharmaceutical industries, the overall purpose remains the same:…

Design Controls Defined

by Charles Ventura, President  Design Controls, do we really have to follow them?  Design Control is a topic that medical device professionals seem to either love or hate. Many Engineers call Design Controls, “the paperwork” or “just the documentation”, and rarely seem to value them.  The thought of having to create the Design Control documentation…