Medical Device Company Updates 450 QMS SOPs in time for EU MDR

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USDM brought together two siloed divisions to ensure QMS documents were updated in time for EU MDR

Learn how USDM helped a large medical device company get ready for the EU MDR deadline using our managed staffing delivery model. We assigned a team of subject matter experts to the project including a project manager, an EU MDR expert consultant, and nine technical writers. The technical writers delivered the equivalent of one man-year of technical writing for SOPs within one month.

• A large medical device company
• The company wanted their QMS SOPs assessed for compliance to the MDR to protect ~$1B of EU revenue
• Director of Quality Programs lacked the resources needed to review and update QMS documents to meet critical EU MDR deadline
• Customer did not have holistic QMS owner who could break down the company and QMS element silos
• The customer was restructuring into a central corporate quality structure
• Projected 300 documents to be reviewed at the onset of the project