Bitwise is certified to ISO13485 and our experience includes a variety of medical devices launched into all significant medical markets.
We apply our extensive embedded system experience, rigorous quality culture and project management skills to deliver software projects that meet Food and Drug Administration (FDA) and EC approvals for medical devices.
Products range from hospital surgical systems to mobile patient devices.
Our services include
Full lifecycle development
From a concept or prototype into a validated and verified product
Design of a robust architectures
for product evolution and roadmap
Hardware platform
selection; design and risk management
Independent
testing, code review and verification
Clinical data management
and interfacing to devices, e.g. DICOM, HL7, telemedicine
Wireless integration and management
of patient data interfaces
Case study
Safety-Critical Medical Devices: Protecting Lives
Bitwise developed a handheld device to support the management of diabetes for a leading Blue-Chip client in the Healthcare Industry.
The Bitwise solution was successful and there are now over 30M devices in circulation worldwide. The device supports patients to manage critical medication that combats the disease.
The product design required high volume manufacture, with software to run on a low specification microprocessor, limited user interface and a constrained power budget. This Class B medical device required Food and Drugs Administration (FDA) certification in addition to European CE marking
A modular architectural approach was selected and incorporated a hardware abstraction layer which allowed for portable code to be developed. The architecture also considered design for testability and maintainability with test point interfaces identified as early requirements.
Bitwise designed and developed all the embedded software running on the device; from the drivers through middleware, algorithm implementation to the user interface. Supporting tools were also developed, including a PC based simulator to aid testing and debugging.
Bitwise continues to support the client, further optimising this crucial device to deliver effective patient outcomes.
