the ability of a medical device or material to perform with an appropriate host response in a specific application

BRA is the overall process comprising a risk analysis and a risk evaluation

In large animals facilitate finalization of product design and provide evidence supports to the safety and efficacy evaluation on device

Strong medical device registration expert team, with professional database and management platform, to provide customers with a full range of medical device registration solutions

Involves evaluation of the clinical benefit-risk profile for the device using the latest available clinical data, e.g. clinical studies, published literature, active post-market surveillance

The most time-consuming, expensive and unpredictable part throughout the development of a device, which must be attached great attention to