Your trusted partner for medical devices.

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


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.

Your trusted partner for high-quality software development


Expertise in secure development.


Delivering solutions in the most complex environments.


Best in class software development for real-time, safety critical systems.


High performance systems for the next generation of networks & services.

Develop your career with Bitwise

Bitwise employ over 80 staff across our offices in Scotland and the Netherlands. Our exceptional people are the reason Bitwise has been at the forefront of safety critical software engineering for over 35 years.