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Biological Risk Assessment

BRAs by IASON

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.

 

Ensure End-User Safety

 

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.

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.