Apr 15, 2020
2019 IMDRF Guidance Changes Related to Clinical Evidence, Evaluation, and Investigations
Sep 10, 2019
The FDA QSIT: Understanding What Happens During a Medical Device QMS Inspection
Nov 19, 2018
What’s the Difference Between a Design History File (DHF), Device Master Record (DMR), and Device History Record (DHR)?
Nov 19, 2018
Medical Device Design Inputs, Outputs, Verification, and Validation. What Do They All Mean?
Nov 13, 2018
Basics of Medical Device Design Controls: What, Why, and How
Jun 27, 2018
Understanding Your Most Important Obligations in ISO 13485:2016 and the US FDA QSR