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Expert toxicology evaluation report – ISO 10993

  • According to ISO 10993-1:2018, the Biological evaluation of medical devices has to be provided as part of the information needed to register a Medical Device.
  • The evaluation aim is the protection of humans from potential biological risks arising from the use of medical devices.
  • At Azierta, we provide comprehensive support covering the biocompatibility evaluation, evaluation of test results when necessary, the risk assessment report of medical devices and its regulatory management .

Our services include:


1. Biocompatibility evaluation

  • Compilation of physical and chemical information on/about the medical device and its associated material characterization process.
  • Material characterization.


2. Testing

  • When considered necessary, biological testing methods for biological evaluation must be sensitive, precise and accurate.
  • Biological tests should be carried out in accordance with good laboratory practices. The test methods should be reproducible as well as repeatable and robust. 
  • Based on the test results, our experts analyse the data and perform risk assessment. 



3. Risk assessment reports for medical devices

  • Expert toxicology evaluation report of a product is carried out to establish its biocompatibility.

“At Azierta we have a multidisciplinary team, our toxicological experts and regulatory team can support you in all the stages of the registration of a Medical Device”

Leading innovation in pharma & health

100 professionals

Over 100 professionals

500 clients

Over 500 clients

9 year experience

9 years of experience

Innovation

Leading innovation

Client oriented

100% client oriented

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