Challenge
Following serious safety failures, the manufacturer faced an FDA mandate to repair, retire, or replace more than 200,000 devices within a year. Corrected designs needed to reach Asia-Pacific manufacturing and U.S. service teams without disrupting other operations.
Response
PMO Partners coordinated design-transfer activities and the interdependent manufacturing, service, and quality work. When a gasket supplier encountered quality problems, team members worked on site to plan and coordinate corrective improvements.
Outcome
The design transfer finished successfully and on time. The source reports that the FDA subsequently allowed the company to resume selling the product. These results concern the historical remediation effort and do not replace product-specific safety information.
An edited client story. Outcomes and figures describe the reported engagement, rather than a promise of results for another organization.