Challenge
A biotechnology company with a cancer-screening product needed to prepare for EU IVDR requirements but lacked dedicated resources. Recent ISO 13485 certification provided useful groundwork, while additional risk, technical-file, and quality-system needs remained.
Response
A PMO Partners consultant assessed quality-system and product documentation, sought notified-body guidance, and compared ISO and IVDR requirements in a shared tracking matrix. A roadmap addressed the largest gaps, particularly risk-management records and related procedures. Governance assigned work to named individuals, including ownership of written rationales where a requirement did not apply.
Outcome
The company gained a visible, prioritized compliance program and reusable planning tools. Executives and functional leaders became more engaged. Work transitioned to the internal team before the program was complete; the source does not establish that market authorization had already been granted.
An edited client story. Outcomes and figures describe the reported engagement, rather than a promise of results for another organization.