A large medical device manufacturer selling products across multiple countries needed to upgrade its Quality System to meet the EU Medical Device Regulation (EU MDR). USDM Life Sciences helped the company revise 400 SOPs, generate CND codes for EUDAMED submissions, and put a clear plan in place for recall items — establishing a compliant quality system in under 8 months and reducing $3B in EU revenue risk.
The Challenge
Every existing device had to be recertified under EU MDR. That meant re-certification of the notified bodies, new submission requirements including new clinical evidence and reasoning (CER) forms, new post-marketing safety analysis and reporting requirements, and changes to the device technical files and dossiers.
For a manufacturer with products in multiple countries, the stakes were high. The company faced several converging pressures:
- Its QMS and 400 SOPs required review and revision to align with EU MDR.
- CND codes for EUDAMED submission had not yet been generated.
- There was no clear plan for how to handle recalls by item.
- An estimated $3B in EU revenue was at risk if recertification slipped.
This is fundamentally a quality and data integrity challenge: hundreds of controlled documents had to be reviewed, redlined, and resubmitted accurately and on a tight timeline, with no margin for error.
The USDM Approach
USDM met with the company's lead regulatory and quality executives to review the process and sequence of activities, then worked methodically through the document landscape:
- Inventoried all policies and procedures affected by EU MDR and reviewed every necessary document.
- Reviewed the remaining policies and procedures to confirm they were not relevant to the EU MDR initiative — scoping the work precisely so effort went where it mattered.
- Assigned select regulatory consultants, matched by skill set and experience, to review and redline policies and procedures in their respective areas of expertise.
- Reviewed all proposed revisions with the relevant regulatory and quality managers.
- Provided hands-on support for the SOP submission processes required for device recertification.
Because the work spanned controlled documents, electronic submissions, and recertification records, USDM applied a quality-by-design and risk-based assurance mindset throughout, keeping document control and traceability intact across all 400 SOPs. For organizations that want to keep that posture beyond a single project, USDM's continuous compliance model sustains quality system readiness as regulations evolve.
The Results
USDM delivered a quality system rebuilt for EU MDR with measurable outcomes:
- < 8 month timeline to establish a Quality System that meets EU MDR requirements.
- $3B in revenue risk reduction across the EU.
- Data ready to submit to the European Database on Medical Devices (EUDAMED), with CND codes generated and a recall-by-item plan in place.
By scoping the work precisely, matching the right consultants to each document area, and supporting the recertification submissions end to end, USDM turned a sprawling regulatory obligation into an on-time, audit-ready quality system — protecting billions in EU revenue and clearing the path to EUDAMED. Talk to USDM about your EU MDR or IVDR readiness.