USDM brought together two siloed divisions to ensure QMS documents were updated in time for EU MDR
Learn how USDM helped a large medical device company get ready for the EU MDR deadline using our managed staffing delivery model. We assigned a team of subject matter experts to the project including a project manager, an EU MDR expert consultant, and nine technical writers. The technical writers delivered the equivalent of one man-year of technical writing for SOPs within one month.
The Situation
- A large medical device company
- The company wanted their QMS SOPs assessed for compliance to the MDR to protect ~$1B of EU revenue
- Director of Quality Programs lacked the resources needed to review and update QMS documents to meet critical EU MDR deadline
- Customer did not have holistic QMS owner who could break down the company and QMS element silos
- The customer was restructuring into a central corporate quality structure
- Projected 300 documents to be reviewed at the onset of the project
The Solution
- USDM assessed the customer’s QMS SOPs for the EU MDR requirements
- USDM presented their observations and findings to customer
- Customer hired USDM to perform all SOP updates
- USDM assigned a team of subject matter experts to the project including a project manager, an EU MDR expert consultant, and nine technical writers
- USDM developed a 4-tier process to tackle the documents: 1) load, 2) review, 3) redline, 4) approve
- Daily status meetings, led by USDM, were set up to keep the team on track
- The scope of the project grew from 300 to 450 documents
- USDM was able to deliver the equivalent of one man-year of technical writing of SOPs within one month by deploying nine experienced technical writers
- USDM was able to bring together two siloed divisions of the customer’s organization to ensure all required QMS documents were updated in time for EU MDR
- Quote from customer: “USDM got more done in a month than we did in the last year.”
The Results
- 450 QMS SOPs EU MDR compliant with the help of USDM
- 9 Technical Writers hired, deployed, and achieved customer objective
- 1 Month to complete project
Learn more about USDM’s flexible delivery models.
