medical device regulatory solutions - Compliance Remediation Support - Ann Arbor, MI
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Compliance Remediation Support

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