Regulatory and Quality Assurance

  • ISO 13485:2016
  • Current Good Manufacturing Practices
  • USDA Licensed Services Provider
    • USDA Audited
    • Approval Number: TN-TEC-0003
    • Approval Number: FL-TEC-0002
  • EC1069/2009 Approved Facilities
  • Production activities documented following cGMP guidelines
  • MLS established IACUC with Humane animal procedures following National Research Council guidelines
  • EAR - Export Administration Regulations
  • DOT/IATA Regulations
  • Change controls applied to modifications of products or processes
  • Manufacturing activities driven by documented procedures and specifications
  • Processes are validated in accordance with defined protocols

For Quality or Technical Inquiries please contact: