Medical Device Regulatory Solutions™ -  » » » global regulatory & clinical research consultants
Regulatory Expertise & Support For Global Compliance
                               » » » Throughout The Product Life Cycle
 
 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
 »  GxP Implementation & Support (GLP,  GMP, GTP & GCP)
 
FDA Inspection Remediation Support Services:
» Prepare 15-Day Responses To 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
 
Global Clinical Trial & Premarketing Submissions:
             IDE, IND, HDE, 510(k), PMA, Tech Files & Design Dossiers
 
FDA Device 510(k), IDE, PMA Submission Process                     Fuller, KL mdrsllc.com