BioCompatibility Testing for Medical Devices
Li-Med is the exclusive representative in Israel of Eurofins Biolab for medical devices. Eurofins is a leading global testing and support services organization, with more than 30,000 staff in an international network of 400 laboratories across 42 countries in Europe, North and South America and Asia-Pacific
Biological evaluation, including biocompatibility,
is a mandatory early step in the regulatory approval pathway of a medical device, as defined in the ISO 10993-1 standard "Biological Evaluation of Medical Devices”.
Through its partnership with Eurofins, Li-Med now offers a full range of GLP- and ISO/IEC-compliant biocompatibility and other biological evaluation tests to Israeli companies that are developing medical device or combination products:
- Dermal and mucosal irritation studies
- Evaluation of intra-cutaneous irritation
- Evaluation of allergenic sensitization
- Assessment of subcutaneous implant, muscle and bone
- Evaluation of genotoxicity
- Determination of toxicity – acute, subacute, subchronic and
- Assessment of degradation products, extractable substances,
residues of ethylene oxide
- Assessment of sterilization effect on the device
- Chemical, physiomechanical, topological characterization
Combining Eurofin's expertise in medical device packaging with Li-Med's expertise in QA and regulation, we design a study protocol that is tailored to your product’s specific regulatory requirements and risk profile.
For more information & quotes of laboratory services, please contact us: firstname.lastname@example.org
For more information on Eurofins’ medical device testing , click here.
Contact Us Now