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MDR Support Fills Stakeholder Gaps

 

INDUSTRY

Medical Device

SERVICES

Regulatory Affairs
European Medical Device Regulations (MDR)

SKILLS

Project Management
Three expert consultants with niche expertise provided on-site in remote European location.

The Challenge

Two key stakeholders were scheduled to be on leave during the initial kickoff of an MDR implementation. To overcome this considerable challenge, the client determined the best course of action would be to seek external assistance for this complex project. However, due to their remote location, it was proving difficult to find the resources with the right experience to support the initiative on site. The client had previously experienced Oxford Global Resource’s unique ability to source experts with niche skill sets quickly, so they contacted us to locate the right talent for the job.

The Solution

Within a minimal timeframe, we were able to provide a Senior Project Manager, PMS Expert, and Compatibility Specialist all experienced in MDR to assist with the implementation. This included support in the following areas:

  • Classification of Medical Devices
  • PMS
  • Clinical Evaluation
  • PSR
  • Risk Management
  • Economical Operators
  • Eudamed
  • Unique Device Identification (UDI)

The three consultants were required to be on site to complete the broad scope of tasks required for implementation. These tasks included project controlling/coordination, gap analysis, updating timelines, regular status reports, collaboration with in-house departments and the requisite Notified Body, and reviewing, planning, and updating tasks for technical documentation. During the initiative, the Oxford Project Manager identified gaps within the change management process and notified the client. Due to his proactive approach, the consultant was able to assist the client in updating their processes to best suit their needs now and in the future.

The Result

Our consultants were able to complete an initial gap analysis. Our proactive approach to the change management process allowed the client to implement new, more efficient change management procedures within three months. We continue to partner with this client to achieve their long-term MDR goals.