Challenge
A large U.S. medical device company had nearly $300 million in European revenue exposed to MDR transition risk. An initial team of about a dozen people underestimated work across roughly 50 product families, more than 50 quality systems, and 11 notified bodies.
Response
PMO Partners established cross-divisional governance, resource and budget planning, and a revenue-informed approach to product prioritization. The program ultimately coordinated ten subteams and more than 120 people, while creating processes for reviewer inquiries and production readiness.
Outcome at publication
Remediation remained underway. One product family had achieved compliance and others awaited review. The source reported that the work was preserving most of the EU revenue at risk and establishing a foundation for surveillance and future regulatory change. It did not report completion across the portfolio.
An edited client story. Outcomes and figures describe the reported engagement, rather than a promise of results for another organization.