Learn how USDM helped a large medical device company get ready for the EU MDR deadline utilizing our managed staffing delivery model.

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 1-man-year of technical writing of SOPs within 1-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, that we did in the last year.”

Learn more about USDM's flexible delivery models here.

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

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