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Risk assessment services for medical product development

Do you need to

  • identify and assess design weaknesses to minimise the risk of product failures?
  • analyse the cause of current problems and implement corrective actions?
  • test products prior to market launch to ensure fitness for purpose and compliance with standards?
  • conduct an independent, rigorous technical audit of design, materials, tooling and production techniques?

Team can help

  • conduct a structured investigation of latent, existing or potential faults associated with the design, manufacture or supply of new products
  • formal risk analysis of designs and processes using complementary risk analysis tools including FMEA (Failure Mode and Effects Analysis) and FTA (Fault Tree Analysis)
  • through detailed assessment of a product’s ‘fitness for purpose'
  • reduce identified risks by consideration of component and system design, manufacturing processes and user issues

 

 
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