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Medical Device Approval Changes in Europe, USA, and Global Markets

The introduction of EU Regulation 2017/745, also known as the Medical Device Regulation (MDR), has fundamentally ...
Sep 20, 2024

Knowledge of the organization in ISO 9001 - What does the standard say?

In many cases, international standards have provided forward-looking impetus and enabled companies to ...
Sep 19, 2024

Sedex SMETA 7: Everything you need to know about the revision

On September 10, Sedex published the revised SMETA methodology version 7.0. The revision brings significant ...
Sep 18, 2024

Happy Mid Autumn Festival

Happy Mid Autumn Festival !
Sep 16, 2024

MDSAP Audit Approach: Enhancing Supplier Selection in Purchasing

The Medical Device Single Audit Program (MDSAP) is designed to streamline the auditing process ...
Sep 13, 2024

When systems fail: what a global outage teaches us about cyber security and quality

Recently, global IT services across industries ranging from aviation to banking, universities and many ...
Sep 03, 2024

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