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When a European medical device manufacturer needed to achieve MDR compliance, they began the process of performing a gap assessment and developing a roadmap to determine what business requirements needed to be met and how MDR compliance could be achieved. However, due to the lack of available resources within the company at the time, they were unable to carry out the complex, fast-moving project while also maintaining their day-to-day operations.
Oxford Global Resources assessed the client’s processes and systems to help them fill knowledge gaps and assist with the many moving parts of the project. We were able to provide four professional consultants to support the client’s European MDR compliance project, which included an MDR project lead and three SMEs: one each for CERs, PMS, and technical file updates. After working with the client to complete an initial gap assessment and identify areas for improvement, these experts worked alongside internal employees and a dedicated PMO lead to quickly establish seven individual workstreams. The objectives of these workstreams consisted of:
Although the client had not previously worked on a compliance project of this scale before, our team was able to swiftly integrate with the internal team and familiarize themselves with product lines, QMS, and IT systems.
After completion of the gap assessment, the client was able to make noticeable progress on their EU MDR compliance project in a short timeframe within each of the seven established workstreams. As a result of our assistance, the client was able to progress and shift their focus to CER work.