Biocompatibility

Eurofins medical Device Testing offers the full range of Biocompatibility Testing required by the Medical device industry. Biocompatibility testing is a critical part of the regulatory approval process for medical devices as even the best designed products can produce unintended complications if the materials used cause a biological reaction in the patient. Well characterized materials widely used in the industry can produce unexpected reactions if processed in a way that leads to contamination, degradation, or leaching of toxic compounds into a patient.

Eurofins Medical Device Testing is ISO 17025 accredited and has expertise in a wide range of products and manufacturing processes to help assess the risks of a new device design or process change, and develop an appropriate testing program for assessing the safety of your products.

From chemical characterization of degradation products and extractables and leachables testing, to toxicological risk assessments and biological evaluations, our veterinarians, chemists, and toxicologists can facilitate the appropriate testing to best support your international regulatory submissions. 

Choose Eurofins Medical Device Testing to help you:

  • Evaluate the biocompatibility of your new device
  • Assess the impact of a design change or new manufacturing process on your device’s safety
  • Evaluate new raw material suppliers
  • Consider effects of sterilization techniques or long-term material stability
  • Generate toxicology reports
  • Review the biocompatibility evaluations for your international regulatory submission
  • Establish biological safety plans and conduct gap analyses of existing biocompatibility dossiers
     

Biocompatibility testing services:

  • Chemical Characterization Testing
    Extractables & Leachables

  • Toxicology
    Toxicological Risk Assessment
     
  • In-Vitro Biocompatibility Testing
    Cytotoxicity
    Development and Reproductive Toxicity
     
  • In-vivo Biocompatibility
    Hemocompatibility
    Systemic Toxicity
    Genotoxicity
    Genotoxicity
    Sensitization
    Irritation
    Subchronic/ Chronic Toxicity
    Implantation  

Questions? Call us now

+31622477880