Medical devices (Dir. 90/385/EEC and 93/42/EEC , Reg (EU) 2017/745)

With the entry into force of the new regulation in May 2017, the area of medical devices is undergoing a massive change. The overall level of requirements has significantly increased and compliance with the general safety requirements remains a crucial point in the development and marketing of medical devices.

The evaluation of biocompatibility is one of the key steps to prove the biological safety of medical devices in a standard context that is more restrictive. 

EquiTox supports you in the biological evaluation process in accordance with the biocompatibility requirements and the current ISO 10993 standards.

1- Evaluation of the biocompatibility of medical devices
Critical analysis of the chemical characterisation results
You have completed and documented the composition, description, manufacturing and use of your medical device and established its classification. Based on the analysis of the results of the preliminary stage of characterisation of the material (ISO 10993-18 and ISO 10993-9, 13, 14 and 15), we carry out a complete bibliographic search (with use of your historical data if available ) and establish the allowable limits for leachable substances according to the current ISO 10993-17 standard. We can deliver you a detailed report with a conclusion on the outcome of the analysis and in particular the possibility or not of adressing the potential risks identified.
Identification of data gaps and establishment of a testing programme
If at the end of the analysis of the chemical characterisation results, it is concluded that potential risks are not controlled, we proceed to the identification of the missing data necessary for the biological safety analysis and establish a biological testing programme based on the ISO 10993-1 and ISO 14971 standards.
Follow-up of biocompatibility tests according to ISO 10993 standards
Based on the testing programme established in the previous step, we manage the follow-up of your studies from the selection of the testing laboratory to the analysis of the results and the validation of the final report. We guarantee that the specificities of your device will be taken into account at all stages of the process. EquiTox undertakes to report to you the results and the progress of the tests according to your needs and to technical requirements.
Analysis and overall conclusion on biological safety
We analyse all the available data (your historical data and bibliographic data) as well as the results of the biocompatibility tests carried out, in order to draw an overall conclusion on the biological safety of your device. This conclusion is directly related to the conclusions of the initial risk analysis that has been updated with the results of the new tests (ISO 10993-1).
Writing and validation of the Biological Evaluation Reports
Our dedicated toxicologist experts assist you in the writing of biological evaluation reports or carry out the evaluation of the reports you have written.
2- Expertise in Toxicology
Support on biocompatibility issues
We provide support throughout the development of your products (from the R&D phase to the placing on the market) on issues related to toxicity (biocompatibility):

  • Bibliographic searches
  • Establishment of toxicological profiles
  • Interpretation of biocompatibility testing results
  • Analysis of non-compliant results and support for the identification of possible causes
3- Training courses
Toxicology applied to medical devices
You are concerned by the evaluation of the safety of medical devices and you need to better understand the biocompatibility of materials, we provide training ranging from basic concepts in toxicology to the study of practical cases.
The fundamentals of the REACh regulation to anticipate the impact on the medical device area
As manufacturers of medical devices, you are impacted by the REACh regulation via the chemicals you use in your processes (manufacturing, cleaning, etc.). We provide training to understand the REACh regulation in order to determine its impact on your business. The notions of restriction and authorisation are particularly critical. Understanding the content of safety data sheets and the interpretation of hazards in relation to a medical device use is also a major concern.
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