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SQA Regulatory Surveillance Summary for May and June 2024

SQA

The EC engaged Gesundheit Österreich GmbH (Austrian National Public Health Institute), Civic Consulting, and Areté to collect data on the availability of medical devices in the EU and the progression of transitions to the Regulation (EU) 2017/745 on Medical Devices (MDR) and Regulation (EU) 2017/746 on In Vitro Diagnostic Medical Devices (IVDR).

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QMS 101: Quality Management System Guide

Dot Compliance

Ensuring Compliance with ISO 9001, EU MDR, FDA & More 6. Quality Management System Development 7. What is Quality Management System (QMS)? Systems for managing quality concerns, enhancing product performance, reducing waste, and driving continuous improvement are all provided by quality management systems.

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