The IEC 80001-1 standard is gaining ground. Designed for the “application of risk management for IT-networks incorporating medical devices,” this ISO standard will require heavy documentation work to become applicable by hospitals.
A need identified by German software editor Bayoo.Net.
This company provides medical device manufacturers with a software platform allowing them to fully manage CE, FDA and CFDA certification of their products. Its tool is therefore a natural fit for hospitals, which need to assess safety of their IT networks.
Among its features, Bayoo.Net can produce standardized safety reports for authorities, share knowledge throughout an institution and help a hospital to contact a manufacturer regarding safety questions.