MDR Transformational Program

Our client, a globally recognized medical device business, reached out to us for help with becoming MDR/IVDR compliant by 2020 after release of the new regulations. This is a significant piece of reform that required immediate action across their entire European Operations.

Challenge

As the client’s business is one of the largest of its kind in the world, they needed specialist support within Regulatory Compliance to meet this deadline, across multiple European countries. The client needed one supplier who could compliantly deliver across every location from one point of contact. Project continuity is key when facing challenges of this magnitude, therefore, retention of the workforce was seen as a significant priority.

Solution


Proclinical worked with the business to identify two critical workstreams that needed support. Firstly, to improve the quality and quantity of clinical data from their sites in France, Germany and Switzerland they needed a specialist team of ten CRA’s. Secondly, a quality management system team was needed in Germany to update their existing QMS according to the new regulations. Utilizing their office in Germany and their SECO license in Switzerland, along with a dedicated multi-lingual resourcing team, Proclinical was able to provide local support quickly and compliantly for each workstream through one point of contact.

Outcome


Quality Compliance

Both teams were compliantly mobilized to each project location within 7 days of SOW creation

Quality Compliance

Retention stands at 100% for the total of 15 consultants provided

Quality Compliance

Single point of contact for this multi-country project saved the client significant time

Quality Compliance

Proclinical is now discussing phase two of the MDR Transformational Program

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