Aran 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
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