The New ISO 13485:2016 - Overview Part two

An interview with Susan Mecca

"If I had to single out one change, it would certainly be the adoption of a risk management based approach throughout all areas of the QMS - from design development, purchasing and outsourced processes, to training and competence."

Susan Mecca, LRQA Technical Manager, Medical Devices

Click on the image below to download the Susan Mecca Interview - Part two