This case study looks at remediating biocompatibility workflows to meet EU MDR compliance requirements. CLIN-r+ supported the manufacturer with their problematic biocompatibility workflows to address audit findings and deficiencies and pass the second NB assessment.
This case study looks at supporting an MDD to MDR transition and how CLIN-r+ supported one manufacturer when they decided on outsourcing EU MDR to allow internal resources to remain focussed on New Product Introduction (NPI).
This case study looks at fast tracked PMCF activities and how CLIN-r+ supported one manufacturer with their Clinical Data Acquisition for EU MDR submission from an MDD Certificate based on Equivalence.
This case study looks at remediating a problematic Clinical Evaluation Report and how CLIN-r+ supported one manufacturer when they decided to outsource EU MDR Clinical Evaluation and Investigations.
This case study looks at supporting an FDA 510k to MDR transition and how CLIN-r+ supported one manufacturer’s journey to enter the European market by leveraging their FDA 510k certificate.
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