Regulatory and Quality Assurance

Our entire staff is dedicated to maintaining the highest compliance standards in the industry including:

• ISO 13485:2003 and 9001:2008
  • Customer audits are welcome and encouraged
    
  
  
• FDA Registered (Saco, ME)
• Analyte Specific Reagents - ASR
• Quality System Regulation - QSR - 21 CFR 820
• FDA-CDRH Audited
  
  
• Current Good Manufacturing Practices (Memphis, TN)
  • 21 CFR 210, 211

• USDA Licensed Services Provider
  • USDA Audited

• EC1774/2002 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

• Design controls applied to new product development

• 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

• Current Good Manufacturing Practices (Memphis, TN)
  • 21 CFR Part 11 EDMS

ISO 9001:2008 Certificate
Memphis, TN