GxP Engagement: EU MDR Implementation Project (MDD to EU MDR)
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.
Project Team Deployed;
- 1 x EU MDR Project Manager
- 1 x EU MDR Program Manager
- 2 Medical Device Quality SME
- Validation Consultant
Thanks to i-Pharm GxP we were well prepared for the new EU MDR Regulations.