Product Development

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

By | 2017-05-11T12:22:41+00:00 April 11th, 2017|Services|0 Comments

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