– Director of Operations – Class II and III device Manufacturer

– Director of Operations – Class II and III device Manufacturer

“I have found that you have provided valuable information and guidance during our relationship over the years. You have responded in a timely manner when we need an opinion on regulatory issues and seem to possess a vast knowledge of the Quality System Regulations. Your ability to provide the FDA perspective on various aspects regarding 510k submissions, audits, and other related activities is beneficial to our compliance efforts.”