Biosafety Assessment Service

A numerous of new medical devices are being introduced every day in the market. The established standards are constantly being redefined. Biohazard assessment, risk characterization and toxicology risk assessment are required for all new medical devices.

In addition, the product must meet the various standard testing requirements of the international market during the development process. Therefore, biocompatibility planning not only satisfies management requirement but also meets business requirement.

 

STC offers a full spectrum of biosafety services so as to assist clients to develop medical device products smoothly. Our services include:

 

- Biosafety Assessment Program

- Testing service

- Biosafety Assessment Report

- Toxicological risk assessment

- Raw material safety survey

- Difference Analysis

- Training and consulting services

- Technical support from NMPA, FDA and notified bodies

- Equivalence assessment

- Peer review

- Technical Memorandum of Bad Detection Results