
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