BiOptic Qamp Master Software has received IEC 62304 Class C Certification

Since BiOptic Inc. obtained the GMP qualification in 2018, ISO13485 is also certified in the same year. However, BiOptic Inc. hasn't stopped there. In order to ensure the safety and effectiveness of medical equipment, BiOptic continue to optimize the medical equipment quality management system based on ISO 13485. In the process of each stage of design and development, the team is strictly required to develop and maintain medical equipment software according to IEC 62304 Standard.

Like most of the regulations related to medical devices, according to the different risk levels of the medical devices themselves, the regulations themselves are often divided into several levels as implementation requirements, which are based on different degrees of requirement strength. This time BiOptic Inc. obtained Class C, the highest level in IEC62304. It is hoped that through such certification, BiOptic Inc. can provide customers with the best quality products and experience.