240+
BERs prepared
800+
materials evaluated
20
years of experience
Abstracting complex documents
Outsource the complete biological evaluation preparation process and profit from a cleanly abstracted process and a well-defined data request interface.
Better understanding
​Discuss your evaluation strategy with our experienced preclinical and regulatory consultants to receive constructive feedback on your plan.
More insight
Benefit from a comprehensive gap analysis performed by a consultant during the preparation of the biological evaluation plan.
Fewer tests
Avoid unnecessary tests by preparing literature-based toxicological assessments to address gaps in your evaluation.
The practical solution for Class I devices
Biological risk assessment (BRA)
The BRA serves as a streamlined version of the BER, specifically designed for Class I medical devices to facilitate cost-efficiency while maintaining regulatory compliance. Operating within the guidelines of ISO 10993-1, the BRA focuses on evaluating the biocompatibility of all materials used in the medical device, including its packaging. This assessment scrutinizes the potential biological risks associated with the device's material, such as cytotoxicity, sensitization, and irritation.