Quality & Regulatory Standards

Costa Rica production line
CRI Medical Devices is US FDA registered, compliant with 21 CFR Part 820, Quality System Regulation, and ISO 13485 Certified. We assist our customers with all of their regulatory requirement needs.  CRI operates with a fully-integrated ERP system and utilizes quality engineering tools and lean methodologies.
 
Our internally developed, state-of-the-art Quality Management System (QMS) is part of the package when you engage CRI from product concept to distribution. We combine a simple, straightforward approach with the attention to detail required for regulatory compliance with ISO, FDA, CE/EU and Health Canada standards. We are here to assist you with efficient and effective preparation for regulatory submission. All new hires at all levels receive FDA QSR (GMP) and ISO13485 training, ensuring critical requirements are understood.
 
IN-HOUSE QUALITY SERVICES
 
  • Design control & documentation
  • Risk management
  • Process yield and defect analysis
  • Statistical Process Control (SPC)
  • Fully compliant calibration and preventive maintenance system
  • Six Sigma methodologies
  • Statistical sampling techniques (AQL, C=0, etc.)
  • Process capability measurement (Cpk, Ppk, etc.)
  • Process validations (IQ/OQ/PQ)
  • Formal Corrective Action and Preventative Action (CAPA)
  • Material traceability
  • Design History File management (DHF)

 

IN-HOUSE REGULATORY SERVICES

We are US FDA registered, compliant with 21 CFR Part 820, Quality System Regulation, and ISO 13485 Certified. We assist our customers with all of their regulatory requirement needs.

  • FDA Premarket Submissions
  • (510(k)/PMA/IDE, etc.)
  • CE Marking
  • Health Canada Registrations
  • Other International Registrations
  • (Australia, Japan, South Korea, Brazil, etc.)