Consulting BioTox by Icare
BioTox by Icare offer :
A pre-study of your dossier and guidance in choosing 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 also be used for CE marking, FDA, Japan, etc.
Your BioTox by Icare road map:
- Biological Evaluation Plan (BEP) (ISO 10993-1)
- Définition of the evaluation strategy from A to Z (TRA -> biocompatibility -> BER)
Toxicological Risk Assessement (TRA)
Characterization analysis (ISO 10993-18 / -17)
Analysis of degradation products (ISO 10993-9 / -13 / -14 / -15)
Biological Evaluation Report (BER) (ISO 10993-1)
MP, packaging, manufacturing and release/degradation product analysis
Inclusion of biocompatibility tests and verification of their validity
Justification for “missing” data and gap-analysis
Toxicological assessments
Toxicological expertise
- Impact analysis of PM, supplier and/or process changes, etc.
- Biological / Toxicological equivalence reports
- Worst-case device definition
CONTAct US
BioTox by Icare for TRA (Toxicological Risk Assessment): :
- Database of over 1,500 substances
- Proven toxicological expertise with authorities/ONs (GMED, TÜV, BSi, FDA)
- Expertise in all types of DM (implants, cements, borderline cosmetics, polymers, alloys, etc.).
- A team with diverse knowledge that we like to share (Toxicology, pharmacology, biomaterials, chemistry)
- Follow-up and support for projects, from characterization to biocompatibility testing.
The BioTox by Icare advantages for BER (BIOLOGICAL EVALUATION REPORT):
- BER accepted/validated by NBs (GMED, TÜV, BSi, FDA)
- Project follow-up and support during audits (ANSM, GMED, FDA)
- Expertise on all types of DM (implants, cements, borderline cosmetics, polymers, alloys, etc.).
- A team with diverse knowledge that we like to share (Toxicology, pharmacology, biomaterials, chemistry)
- Proximity to Research Directors for biocompatibility, overview of biological evaluation