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.