Clinical Evaluation Reviews

  • Structured review to meet current requirements MedDev
  • Systematic search, review and selection
  • Analysis and review results
  • Recommendations

Biological Evaluation Reviews – Biocompatibility as per ISO 10993 Pt 1 (2016)

  • Biological risk assessment
  • Information gathered from published literature on the raw materials, manufacturing process data ETC
  • Final pack and sterilisation
  • Ageing impacts
  • Preclinical or clinical studies.

Guidance, direction or management of development activities

Guidance and consulting regarding NICE procedures

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