10 Things You Should Know About The Medical Device Single-Audit Pilot
This article was originally published in The Gray Sheet
Executive Summary
After a long build up, four international regulatory authorities officially rolled out the Medical Device Single Audit Program pilot this month. Here are 10 things companies should know about the program.
You may also be interested in...
Canada Sets 2019 Target For Mandatory Adoption Of Single-Audit Program
The global Medical Device Single Audit Program will become the sole mechanism to demonstrate compliance with Canadian quality management system requirements beginning January 2019.
Top 15 In '15: The Most-Read "Gray Sheet" Stories Of The Year
The most popular "Gray Sheet" stories in 2015 dug deep into regulatory developments and concepts, and provided guidance on how to respond. Quality control topics and analysis of FDA's premarket review processes dominates the list.
FDA Kills ISO Voluntary Audit Program As MDSAP Efforts Accelerate
The agency has terminated a 2012-launched ISO 13485 voluntary audit program, which gave companies the chance for a one-year reprieve from an FDA inspection, to put all attention on the global Medical Device Single Audit Program.