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Apr 15, 2020

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

May 14, 2018

The US FDA is Shifting Toward ISO 13485. But How Much and How Soon?


Sep 20, 2017

How Quality System Harmonization Supports Growth

Jun 22, 2017

CAPA and P&PC: How to Handle These Two Medical Device Compliance Troublemakers

Mar 17, 2017

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