GxP Engagement: EU MDR Implementation Project (MDD to EU MDR)
The Project.
EU MDR Implementation Project (MDD to EU MDR)
The Case.
Partnering with Medical Device client to manage the remediation of legacy products and associated documentation for resubmission and approval for the new and upcoming EU MDR regulations.
The Solution.
Project Team Deployed;
- 1 x EU MDR Project Manager
- 1 x EU MDR Program Manager
- 2 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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