Blog

Mar 17, 2017

FDA Proposes Expanding the List of 510(k) Exempt Devices: What You Need to Know

Feb 02, 2017

Case Study: Assembling a Comprehensive Risk Management Approach

Nov 30, 2016

The Medical Device Single Audit Program (MDSAP): What You Need to Know

Sep 29, 2016

The New EU In Vitro Diagnostic (IVD) Regulation: What You Need to Know

Sep 13, 2016

ISO 13485:2016 Applying the Updates

Sep 13, 2016

ISO 13485:2016 and ISO 9001:2015: Are They Aligned?