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IASON consulting evaluates sterile and non-sterile medical devices that come into direct or indirect contact with the human body with regard to biocompatibility and in compliance with ISO 10993-1.
IASON consulting is a trusted partner for more than 15 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.
Protective
The primary purpose of a device biological evaluation and biocompatibility assessment is to protect patient from potential biological risks.
Interactive
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.
Diverse
When developing and manufacturing a medical device and accessories, the assessment of biological risks should include evaluation of endpoints such as cytotoxicity, sensitization, irritation or systemic toxicity; however, studies may not always be necessary for your product.