Navigating QMS Requirements from a Medical Device Perspective

Navigating QMS Requirements from a Medical Device Perspective Image

Having a different number of pharmaceutical classified products in your portfolio provides a challenge in EU. As distribution and sales of MD products are under MDR, while pharmaceuticals are under EU-GDP and require a wholesaler dealer authorization (WDA). By efficient support from our QA consultant, the client was able to update their QMS and meet current GDP requirements.

Case Study


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