FDA added the following standards to their recognized standards list and published the new recognitions January 2015. IEC TR 80001-2-5 2014. Application of risk management for IT networks incorporating medical devices–Part 2-5: Application guidance–Guidance on distributed alarm systems. IEEE Std 11073-10425- Health informatics 2014. Personal health device comunication, Part 10425: Device Specialization–Continuous Glucose Monitor (CGM)....Read More