Navigating QMS Requirements From A Medical Device Perspective

Our client is a significant presence in the medical device industry, providing MD-classified utilities and equipment to hospitals worldwide, alongside a smaller selection of pharmaceutical-classified products. Operating on a global scale poses challenges in the EU, where distribution and sales of MD products fall under MDR regulations, while pharmaceuticals adhere to EU-GDP standards, requiring a wholesaler dealer authorization (WDA).

With effective support from our QA consultant, the client successfully updated their QMS to meet current GDP requirements.

Get all the details of what happened next by downloading the case study below.