Biocompatibility of Medical Devices according to ISO 10993-1 series

  • Biocompatibility of Medical Devices according to ISO 10993-1 series 1
  • Biocompatibility of Medical Devices according to ISO 10993-1 series 2
Product Description

Galileo Research can drive the nonclinical development of your medical device by preparing the Literature Report and the Biological Evaluation Plan (BEP) according to ISO 10993-1, performing additional tests, if needed, and releasing the Biological Evaluation Report (BER).

All tests can be conducted at Galileo Research according to ISO 10993-1:2018 ("Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk management process) and ISO 10993 standard series, OECD and GLP guidelines

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galileo research

  • IT
  • 2023
    On CPHI since
  • 2
    Certificates
  • 1 - 24
    Employees
Company types
Contract Research Organisation (CRO)
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Contract Research Organisation
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Specifications
  • Model
    Biological evaluation of medical devices consists in the review and evaluation of existing data and the selection of potential additional tests to guarantee the safety of the product
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galileo research

  • IT
  • 2023
    On CPHI since
  • 2
    Certificates
  • 1 - 24
    Employees
Company types
Contract Research Organisation (CRO)
Primary activities
Contract Research Organisation
View company profile

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