News & Evens

BiOptic has certificated by UL in conformance with FDA 21 CFR Part 11

Company News


2021 - 02 - 19

The software system of Qsep series bio-fragment analyzer, Q-Analyzer, which is developed by BiOptic, has certificated by UL in conformance with FDA 21 CFR Part 11 in Jan 2021. The FDA guidelines for Data Integrity include the requirement for compliance for the storage of electronic records. Nearly all the medical-related industries follow this standard, which gains on the safety of information security and data management of the product. The data retained in this standard can be used as an effective source for future tracking.


Q-Analyzer is bundled with our core product Qsep series, which generates the analysis and report automatically. Qsep series possessed multiple certificates including ISO13485, GMP and Class-I medical device. The products of BiOptic can be applied to several different industries, which data administration and information confidentiality will be very important. By concerning this market demand, the R&D department of BiOptic started to redesign and optimize the system, and was certificated since Jan 2021, hoping to offer a safer and better-quality product for our users.