Medical Device Regulatory Solutions™ -  » » » global regulatory & clinical research consultants
Regulatory Expertise & Support For Compliance Remediation
 
21 CFR Part 803: Medical Device Reporting (MDR)
   » Assist with Product Failure Investigations - Failure Mode Root Cause Analysis
    » Global MDR Reporting Decision & Filing Support - FDA eMDR & ESG
   » Corrective Action Implementation Plans
 
21 CFR Part 806: Corrections & Removals
21 CFR Part 7: Recall Support
    »  Health Hazard Evaluations (HHEs)
   »  Recall Strategy Preparation & Implementation
     »  Recall Communications Support
    »  Recall Status Reports
    »  Recall Effectiveness & Termination Support
 
FDA Unique Device Identification (UDI) Compliance
    » UDI Compliance Planning & Implementation Support Services
 
Global Quality Systems Support
   »  Conduct On-site QSR /  ISO 13485 Gap Assessments & Improvement Plans
   »  Conduct Mock FDA / Health Authority Inspections
   »  SME Preparation & Training Workshops
 
FDA Inspection Remediation Support Services:
   »  Prepare 15-Day Responses To Address FDA 483 Observations or Warning Letters
   »  Prepare Comprehensive Quality Improvement Plans (cQIP Package)
   »  Quality Improvement Plan Implementation (cQIP) Support Services
   »  Consent Decree: 3rd Party cGxP Experts & Regulatory Support