If you’re designing, marketing, or selling a medical device, you’re surely familiar with the fact that risk management is an ever increasingly important regulatory requirement and topic. The international ISO standard for risk management is 14971:2019; with few exceptions, regulating bodies worldwide recognize ISO 14971 as the requirement for a risk management process that will…
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:…
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…