Biological evaluation

  • A pre-study of your dossier and guidance in the choice of your testing strategy -Biological Evaluation Plan (BEP).
  • Advice and expertise: risk analysis, Biological Risk Assessment, worst case strategy, evaluation of your dossier, interpretation of physico-chemical test results in accordance with ISO 10993-17.

 

Your road map

Biological Evaluation Plan (BEP) (ISO 10993-1)

  • Definition of the evaluation strategy from A to Z

Toxicological Risk Assessement (TRA)

  • Analysis of the physicochemical characterization of releargables/extractibles (ISO 10993-18 / -17)
  • Analysis of degradation products (ISO 10993-9 / -13 / -14 / -15)

Toxicological expertises

  • Impact analysis of changes in PM, suppliers or/and processes, etc. .
  • Biological / Toxicological equivalence report
  • Worst-case device definition

Biological Evaluation Report (BER) (ISO 10993-1)

  • Raw materials analyses, packaging, manufacturing and release/degradation products analyses
  • Inclusion of biocompatibility tests and verification of their validity
  • Justification for “missing” data and Gap-analysis
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