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MDR Consultants can help with:
- ✔ QMS transition to the EU MDR or MDSAP
- ✔ FDA 483 Response
- ✔ Implementation of ISO 13485:2016
- ✔ Implementation of ISO 14971:2019
- ✔ Gap Analysis
- ✔ Risk Management
- ✔ Quality Management System Procedures
- ✔ Technical File Generation and Maintenance
- ✔ Post Market Surveillance (PMS)
- ✔ Remediation Projects or Initiatives