Medical Device Company Updates 450 QMS documents in time for EU MDR

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.”

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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

Medical Device Company Updates 450 QMS SOPs in time for EU MDR