Design Control

Jul 23, 2023

Understanding FDA and EU Medical Device Labeling Requirements

Nov 15, 2021

How FDA Distinguishes Between Medical Device Servicing and Remanufacturing

Oct 16, 2020

Future Proofing Your Medical Device QMS for Global UDI Expansion

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