Biocompatibility of Medical Devices according to ISO 10993-1 series

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

galileo research

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

galileo research

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

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