MDR Remediation

Why:

One of our main clients was facing challenges in hiring a seasoned biocompatibility expert to handle their MDR remediation plan with a focus on pre-clinical safety assessment.

Due to the unavailability of a suitable candidate, the manufacturer sought external assistance.

We supported the client with a dedicated Project Manager (PM) and, in the backstage, an entire team of expert staff to efficiently manage and address the manufacturer's issues.

Our goal was to provide and even exceed the expertise required by having a team instead of a single expert, which would increase flexibility and capability (team vs single contributor).

For Whom:

This case study is targeted towards manufacturers in pharmaceuticals, medical devices, and biotechnology, seeking external highly skilled support to overcome expertise gaps or resource limitations in RA/QA related areas.

How:

Dedicated Project Manager (PM): Recognising the manufacturer's need for expert guidance and streamlined management. The PM took charge of planning, organising, and executing the required activities (BEP, BER and TRA), ensuring effective coordination and communication throughout the project.

Expert Staff Support: In addition to the PM, a team of highly skilled experts were always available. The staff possessed diverse expertise in various domains, enabling them to address the manufacturer's specific challenges and requirements effectively.

Enhanced Productivity and Flexibility: By providing a team of experienced professionals, we significantly enhanced the manufacturer's productivity and operational flexibility.

Outcomes:

Improved Biological Evaluation: The manufacturer received comprehensive and expert-driven biological evaluation, in line with ISO 10993-1 and in compliance with MDR requirements.

Broader Expertise: Access to a diverse team of experts allowed the manufacturer to tap into a wider range of specialised knowledge and experience with tracked records to fulfill NB requests.

Reduced Overhead: By outsourcing biocompatibility expertise, the manufacturer minimised the overhead associated with hiring and maintaining an in-house SME.

Long-Term Partnership: The collaborative partnership allowed our client to access our expert support whenever required, fostering a long-term relationship for future projects.