Schedule a free 30-minute call with an experienced MDR Consultant to get clarity on how we can help you achieve your goals.
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 Procedure(s) Generation
Pre-market Submissions and Licensing (PMA, 510k, Registration, EUDAMED, MHRA, etc.)
Technical File Generation and Maintenance
Post Market Surveillance (PMS) Implementation & Improvement
Remediation Projects or Initiatives