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.
