GxP Engagement: EU MDR Implementation Project (MDD to EU MDR)
The Project.
EU MDR Implementation Project (MDD to EU MDR)
The Scope.
i-Pharm GxP was engaged under a defined Scope of Work to support a medical device client in managing the remediation of legacy products and associated documentation for resubmission and approval under the new EU MDR regulations.
The Solution.
To execute the agreed Scope of Work, i-Pharm GxP deployed a dedicated project team:
- 1 x EU MDR Project Manager
- 1 x EU MDR Program Manager
- 2x Medical Device Quality SME
- Validation Consultant
The Outcome.
Successfully managed and oversaw a Gap Assessment of current legacy products and new products across Class I-III. Prepared and resubmitted 20 products for certification.
Thanks to i-Pharm GxP we were well prepared for the new EU MDR Regulations.
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