Challenge
An ophthalmic manufacturer needed to remediate hundreds of established products for EU MDR while requirements, deadlines, sponsors, and staffing changed. New development competed for the same teams and expertise.
Response
PMO Partners assessed portfolio gaps, prioritized high-risk and high-value products, and introduced stage gates, technical-file dashboards, and a decision log. The log preserved the reasoning behind earlier choices through reorganizations and leadership turnover. The team staggered submissions to reduce resource peaks and used lessons from earlier files to improve consistency.
Outcome
Over six years, the program guided more than 200 SKUs representing over $140 million in annual business through remediation. The handoff included documented decisions, refined processes, and stronger accountability. Consistent leadership helped the organization maintain momentum while adapting its plans to changing regulatory and business conditions.
An edited client story. Outcomes and figures describe the reported engagement, rather than a promise of results for another organization.