8,000 Records Reviewed within Four Months for Medical Device Client

INDUSTRY
Life Sciences

SERVICES
Mergers & Acquisitions
Auditing

SKILLS
Project Management
Technical Reviews
Non-Conformance Reporting

The Challenge
During an acquisition, many elements need to be considered. This process becomes even more complex when a multinational medical device organization undergoes an acquisition. Our client had undergone post-acquisition audits from the FDA, and several gaps were identified surrounding field complaints, design control, and risk management. As a result, they had 8,000 records of non-conformances that needed to be reviewed, documented, and appropriately escalated within four months.

The Solution
Because we had an existing relationship with this client, they trusted us to carry out this project promptly yet thoroughly. We provided a Project Manager and 10 Technical Reviewers, Plant Quality Engineers, and Manufacturing Quality Engineers. These individuals divided into groups to review each file and classify it based on severity. From there, the file was escalated and documented correctly. While the Oxford team was working with the client’s internal team, the project manager was also coordinating with the team in Germany to ensure all NCRs were tracked and reported. In addition, we had weekly meetings with the Project Manager to ensure the project was on track.

The Result
With Oxford’s support, the client completed all 8,000 record reviews within the four-month deadline and avoided any consent decrees.