Proxy Biomedical provides customers with a verification and validation management service to help them meet the challenge of FDA and MDD directives:

• Product specification establishment (design inputs)
• Design risk analysis (FMEA)
• Design verification and validation protocol generation
• Material/component/product specification and traceability management
  • Test method development and validation
  • Testing execution and report generation:
  • bench testing
  • predicate testing
  • shelf life / stability studies
  • packaging/labelling qualification
  • biocompatibility
  • transit and climatic conditioning (ISTA)*
  • clinical literature reviews

*outsourced