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