ISO 13485:2003

Our ISO 13485:2003 quality system is registered through BSI and complies with FDA’s 21 CFR Part 820.   We can assist with specific quality or regulatory requirements or ultilize our systems to bring your ideas to market:

  • Flexible quality system to match specific needs
  • Procedure and process development
  • Regulatory submission assistance
  • Sterilization management including dose audit management
  • Biocompatibility systems
  • Design History Files
  • Device Master Record,
  • Pre-Market Approval Documentation Packages