Announcing the 2019 MedTech Regulatory Awards Recipients

2019 MedTech Regulatory Award Recipients   The second annual MedTech Regulatory Awards will take place the evening of September 23rd in Philadelphia. This year, the night will focus on the overall outstanding contributions of regulatory professionals and their...
Regulatory Update #190901– USA FDA

Regulatory Update #190901– USA FDA

Regulatory Update- USA FDA September 2019 NEW STANDARD: AAMI TIR102:2019 U.S. FDA 21 CFR mapping to the applicable regulatory requirement references in ISO 13485:2016 Quality Management Systems.  This document provides a mapping of the US FDA 21 CFR requirements to...