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Services >> Biocompatibility Testing >> Toxicological Risk Assessment

Toxicological Risk Assessment

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Medical Device AutoclaveEurofins Medical Device Testing has more than 30 years of experience in safety testing for biopharmaceuticals, chemicals, and medical devices. This experience will provide you with the technical advice to ensure the success of your product development.

Our toxicologists perform genetic toxicology assessments, alternative toxicology assessments and toxicological risk assessments to help understand the safety profile of your medical device. Based on ISO 10993-17, Eurofins Medical Device Testing will identify and evaluate additives, colorants, processing aids, and any existing toxicity and human exposure risks for the final product and individual chemical compounds. Once identified, Eurofins Medical Device Testing uses the profiles to determine additional analytical testing needs for further investigation of unknown entities.

Choose Eurofins Medical Device Testing to help you:

     ✔  Profit from our network of experts who will help you with advice and action
     ✔  Meet international guidelines to achieve the best solution for your product
     ✔  Successfully meet testing challenges and prevent costly production problems and delay
     ✔  Provide competent support for complex tasks

Microbiology Services

  • Clean room requirements
  • Clean room classes
  • Process line consulting
  • Cleaning validation
  • Sterilization validation
  • Reprocessing of medical devices
  • Disinfection validation

Biocompatibility Services

  • Creation of certificates and/or expert statements
  • Biocompatibility assessments
  • Global regulatory strategy
  • Consulting and Customer Support
  • Test strategy development
  • Safety plan creation
  • GAP analysis
  • Validation of studies
  • Risk plan review
  • Biological safety plan
  • Extractables & Leachables review
  • Toxicological Support