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