Biological evaluation

  • A pre-study of your dossier and guidance in the choice of your testing strategy.
  • 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.

Thanks to their compliance with Good Laboratory Practice (GLP) and current standards, the reports from these studies can be used for CE marking, FDA, Japan, etc.

Your road map

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

  • Definition of the evaluation strategy from A to Z (TRA -> biocompatibility -> BER)

Toxicological Risk Assessement (TRA)

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

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

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

Toxicological expertises

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