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Medical device

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The legislation on medical devices is in the midst of a revolution, with the entry into force of the new regulation. The overall level of requirements has increased significantly and safety remains a crucial factor in the development and placing on the market for medical devices.

Biocompatibility assessment is a key step in demonstrating the biological safety of medical devices against the backdrop of a stricter legislation.

I wish to assess the biocompatibility of my medical device

I need a critical analysis of my chemical characterisation results (ISO 10993-18)

Equitox

  • Carries out a comprehensive literature review (making use of your historical data if available),
  • Determines allowable limits for leachable substances as set out in standard ISO 10993-17 in force,
  • Produces a detailed report outlining the outcome of the analysis with regard to potential risks identified.

I need to refine my risk assessment

Equitox

  • Identifies missing data and establishes a testing programme based on standards ISO 10993-1 and ISO 14971,
  • Monitors your studies from the choice of laboratory to the analysis of results and validation of the final report,
  • Guarantees that the specific features of your device will be taken into account every step of the way.

I need a Biological Safety Evaluation (BSE) or a toxicologist to validate an existing BSE

Equitox

  • Analyses all data available (your historical data and bibliographic data) as well as the results of the biocompatibility tests conducted, to draw a conclusion on the overall biological safety of your device,
  • Proofreads the Biological Evaluation Report (BER) as well as all documents used in the establishment thereof,
  • Analyses risks and verifies permissible limit values, taking all leachables into account,
  • Writes or updates BSE reports, adjusted to the format of your choice, while complying with regulatory requirements.

I would like assistance from the R&D phase to anticipate all impacts as early as possible

Am I affected by REACh?

As a manufacturer of medical devices, you are affected by the REACh regulation via the chemicals you use in your processes (manufacturing, cleaning, etc.).
Equitox contributes its expertise in:

  • The hazards of substances as part of the use of medical devices,
  • Substances subject to restriction or authorisation,
  • SVHCs, Endocrine Disruptors, etc.

How can I optimise the development of my Medical Device?

Equitox guides you through the development of your products (from the R&D phase to the placing on the market) on issues relating to toxicity (biocompatibility):

  • Literature reviews,
  • Determination of toxicological profiles,
  • Interpretation of biocompatibility test results,
  • Analysis of non-compliant results and assistance in the identification of possible causes.

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