medical device regulatory solutions - Regulatory Affairs Support - Ann Arbor, MI
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Regulatory Affairs Support

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