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Biological evaluation
Biological evaluation is key for every medical device with patient contact. Let our experts support you in planning and conducting a thorough biological evaluation that is compliant with ISO 10993-1.
Biological evaluation of medical devices
Biological safety must be evaluated according to ISO 10993-1 for every medical device and in vitro diagnostic device that contains materials with direct or indirect patient contact. The process begins by understanding the device from a biological perspective, including its materials, manufacturing processes, and intended use.
A gap analysis is then performed to determine which biological data already exists and which are still needed to demonstrate that the device is biologically safe. Any gaps are addressed through a planned strategy - for example, by conducting additional biological, chemical or physical testing or providing appropriate scientific justifications. When all required data have been collected and assessed, the conclusions are compiled in a comprehensive Biological Evaluation Report.
Our team of experts can support you with:
- Writing the biological evaluation plan, including performing gap analysis of existing biological data to determine which biological data already exists and which are still needed to demonstrate that the device is biologically safe.
- Coordinating biological and chemical tests to be performed with test labs
- Writing toxicological risk assessments
- Writing biological evaluation reports
- Help with answering biological safety related questions raised by notified bodies and authorities
- Offering custom training for biological evaluation
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