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Apr 15, 2020

2019 IMDRF Guidance Changes Related to Clinical Evidence, Evaluation, and Investigations

QSIT Audit

Sep 10, 2019

The FDA QSIT: Understanding What Happens During a Medical Device QMS Inspection

Paperwork Overload

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