ISO 13485:2016 - New terms to take note of
In the new edition of ISO 13485:2016 16 new terms are added with longer definitions. Here is what are the differences and similarities between the editions.
ISO 13485:2016 – Creating a Glass Ceiling for Startups
ISO13485:2016 puts a glass ceiling on medical start-ups with a daunting new array certification requirements that will disproportionally impact them.