Certification of Medical Apps
In January 2016, Biobedded Systems GmbH in Gladbeck was successfully certified by TÜV Nord for the development of medical devices in the field of medical software. This annex II according to the directive 93/42 EEC enables the company to bring Medical Devices up to class IIb as a manufacturer in the sense of the directive in the market.
In addition, the external development of medical software and hardware is covered by the EN ISO 13485 certificate. ProSmap© is the latest development from biobedded systems GmbH. The software module enables systems to be operated via smartphone, tablet or computer – and now with a connection to your own cloud. The consistent separation of the user interface and the device allows for cost-effective development and production, as well as the implementation of complex graphical user interfaces (GUI) even for small devices. This enables a user-friendly interface for all target groups. The bidirectional communication can be carried out both wired (USB, serial, audio) and wireless (WLAN, Bluetooth). This means that even demanding tasks can be implemented quickly and cost-effectively. The end result is a certifiable software app in many possible medical fields. In addition, the data can be stored on a central memory and made available to hospitals or doctors. This is intended to support diagnosis (telemedicine).
According to the manufacturer, the following variants are offered:
ProSmap© Audio
Bidirectional communication via audio interface (headphone jack).
Advantages: Extremely low-cost solution (ultra low cost). Widest distribution in the market. Shortest development times (time to market). Can also be used as a galvanically isolated communication path for medical devices.
ProSmap© Serial USB
Bidirectional communication via USB interface.
Advantages: Affordable hardware and thus low system costs.
ProSmap© WLAN
Wireless bidirectional communication via WLAN radio connection. This radio connection not only allows high data rates with high data security, but also fast system response times. The IP allocation can be done as a fixed IP or optionally as a DHCP server.
Advantages: wireless, fast connection with high data rates. Secure login process via network key. Can also be used for battery-powered target systems.
ProSmap© BlueTooth
Wireless bidirectional communication via Bluetooth radio connection.
Advantages: wireless, fast connection. High prevalence of Bluetooth-enabled end devices. Inexpensive hardware and thus low system costs.
ProSmap© Bluetooth LE
Wireless bidirectional communication via Bluetooth 4.0 low energy (Bluetooth Smart) radio connection.
Advantages: Wireless, fast connection to battery-powered end devices (wearables). High prevalence of Bluetooth LE-capable end devices. Single-chip solution, thus inexpensive hardware and low system costs.
