Congratulations! BiOptic's Analysis Software has certified by IEC 62304!
2022-04-07
BiOptic Inc., as a biotechnology company with R&D, manufacturing, and marketing momentum. To extend the product market to clinical related fields, we followed all software develop guidelines for BiOptic instrument products and has been certified by FDA 21 CFR Part 11. Recently, the operation and database control system: Q-Analyzer and Qamp Master Micro PCR program software are also certified by IEC 62304.
BiOptic’s innovative CE products are listed in the 2022 Market & Research Report !
2022-03-28
BiOptic’s innovative CE products are well positioned within the multi-million dollar Capillary Electrophoresis (CE) Market and rapidly gaining ground to be the industry leader.
BiOptic Inc., Giant Bio Technology Inc. and NTOU have jointly publised a journal article on MDPI
2022-02-17
According to the 2018 market survey report, the global farmed shrimp market is about 28 billion U.S. dollars. Due to the globalization and high-density of aquaculture industry, the spread of diseases has accelerated. Among them, shrimp infectious diseases will outbreak every few years, including white Spot disease (WSD), acute hepatopancreatic necrosis disease (AHPND), and hepatopancreatic microsporidia (HPM), which reduce the industry profit with an estimated $7.8 billion annually.
BiOptic Inc. was listed on Taiwan’s Emerging Stock Board from Q4, 2021
2021-12-28
BiOptic Inc.’s self-developed COVID-19 test kit has been formally submitted to the European Union a few days ago to apply for in vitro diagnostic medical device (CE-IVD) certification.
BiOptic has certificated by UL in conformance with FDA 21 CFR Part 11
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.
As the weather turned cooler in parts of the northern hemisphere, the COVID-19 pandemic is getting serious again in lots of countries. From the beginning of this pandemic, every health organization around the world has put a lot of efforts on finding the right strategy to stop it. Somehow, it seems that there is no effective way.
