EU IVDR/MDR transition impacting 2,000+ SKUs across 144 countries required complete technical file updates, clinical evidence generation, and notified body submissions with tight deadlines.
Comprehensive IVDR/MDR transformation program with gap analysis, technical documentation remediation, clinical evaluation reports, notified body strategy, and global regulatory submissions management.
- 100% on‑time IVDR/MDR compliance across all markets
- 2,000+ technical files updated and submitted
- $50M+ revenue protected from potential market withdrawal
Showcases ability to manage complex global regulatory transformations affecting entire product portfolios with zero compliance failures.
- 5 notified body relationships managed simultaneously
- Clinical evaluation reports for 500+ high‑risk devices
- Post‑market surveillance system redesigned for MDR Article 83
