Support and Guidance for MDR Compliance

 
INDUSTRY
Surgical Instruments
SERVICES
European Medical Device Regulations (MDR)
SKILLS
Risk Mitigation & Management
Quality Assurance
Initial gap assessment completed within two months.
The Challenge

A medical device manufacturer of surgical tools was beginning their MDR compliance journey. As they had limited resources and knowledge of MDR, they decided to pursue outside support. Due to Oxford Global Resources’ organized, hands-on approach and oversight of the project, the client felt more comfortable partnering with us.

The Solution

Two Oxford Quality Assurance Subject Matter Experts were selected to guide the client through an initial gap assessment of all product files. The consultants thoroughly reviewed all documentation including design history files and CERs to identify gaps and areas for remediation as the client moved from MDD compliance to MDR.

The Result

The consultants completed the initial gap assessment within two months. The client was able to strategically leverage Oxford’s services in order to prevent interruptions in their new product launch that coincided with their EU MDR efforts.

The consultants' contract was expanded to help support enhancement and development of technical documentation for submission to the Notified Body across seven different product families, including:

  • Development of Technical File table of contents
  • Support of GSPR Checklist population
  • Post Market Surveillance plans
  • PMCF user feedback forms
  • PSUR/PMS reports

Due to our ability to take ownership of the project from the beginning, regular status reports, and unmatched consultant talent, the client was able to trust their initiative was being handled with the right expertise and knowledge.