Case Study: EU MDR Compliance

1/28/2020

Case Study 1

Challenge

A top 5 medical device manufacturer needed to update over 500 different technical files to conform with the new European Medical Device Regulation (MDR). 

Action

Black Diamond Networks (BDN) quickly identified several highly experienced regulatory project managers with strong knowledge of EU MDR regulations. Our consultants worked collaboratively with the client to develop a strategy and detailed project plan using BDN’s flexible staffing model.

Results

BDN regulatory project managers successfully managed teams tasked with changing, updating, and revising documents within 500 different technical files based on new EU MDR requirements. Our consultants ensured timelines and deliverables were met, all while providing complete project oversight. Consultants were heavily involved in strategic planning, scheduling, coordination, and management of various teams including R&D, product development, regulatory, clinical, and more.

In total, BDN placed over 20 consultants in support of this project and has since been awarded additional EU MDR compliance projects.

Case Study 2

Challenge

A leading global medical device manufacturer needed help writing clinical evaluation reports (CERs) and creating new processes to ensure compliance with new essential requirements of EU MDR.

Action

BDN supplied the client with a team of 12 medical writers, clinical affairs managers, and global medical safety specialists who worked collaboratively with the client to write CERs, as well as setup, develop, and build the processes, plans, and templates needed for EU MDR compliance for post-market clinical follow-up (PMCF).

Results

BDN consultants worked under minimal supervision to write 29 CERs, create new processes, establish a complete PMCF process, including development, plans, and reports, as well as  reviewing all adverse event reports related to marketed products per timeline.