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.
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.