What To Do (And What Not To Do) When You Receive a FDA Audit Notice
Receiving an audit notice from the FDA can be a daunting experience, but it also presents a great opportunity for your medical device company to demonstrate…
Preparing For Your First FDA or ISO Audit
Our recent blogs on preparing for your first FDA inspection and/or ISO audit generated a lot of interest, and a lot of follow-up questions from emerging…
How To Prepare For Your First ISO Audit
Overview of ISO 13485:2016 ISO 13485:2016 is the industry standard for quality management systems for medical devices. Medical device specification developers, manufacturers, and distributors seek certification…