Shopping Cart
Your Cart is Empty
Quantity:
Subtotal
Taxes
Shipping
Total
There was an error with PayPalClick here to try again
CelebrateThank you for your business!You should be receiving an order confirmation from Paypal shortly.Exit Shopping Cart

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