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 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

Biocompatibility Testing/

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:

  •     Cytotoxicity
  •     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 
        chronic 
  •    Haemocompatibility
  •    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: sally@li-med.com

 

For more information on Eurofins’ medical device testing , click here.

 

 

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