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Biological Risk Assessment


IASON consulting is a trusted partner for more than 17 years in the health science sector. You can rely on us and our professional consultants as a reliable partner to determine the specific testing necessary for your very device in compliance with today’s and tomorrow’s regulatory requirements for market access and ongoing market presence.


Ensure End-User Safety



The primary purpose of a device biological evaluation and biocompatibility assessment is to protect patient from potential biological risks.



Medical devices are typically subject to biological evaluation and biocompatibility testing to assess the interaction between a device and tissue, cells, or body fluids of the patient.



When developing and manufacturing a medical device and accessories, the assessment of biological risks should include evaluation of endpoints such as cytotoxicity, sensitisation, irritation, or systemic toxicity; however, studies may not always be necessary for your product.

Get in Touch

Profit from up to two hours of free, not binding consultancy by a seniour consultant at first contact, and see for yourself how we can provide support that saves you time and resources. We are looking forward to it.