Medical Devices
Regulated digital health software, built with care
Bitjam designs and develops regulated digital health software, digital therapeutics and medical device applications for research, clinical and real-world healthcare settings.
We work with universities, NHS teams, clinicians, researchers and commercial partners to turn clinical expertise and research evidence into safe, secure and usable digital products.
Medical device software with real clinical understanding
Regulated digital health products need more than good software. They need to be clinically safe, technically robust, accessible, secure and appropriate for the people and services using them.
Built with healthcare realities in mind
Bitjam brings together digital development experience with a strong understanding of healthcare, research and clinical environments.
Shaped with the people who use it
We work with the people who understand the clinical need, service pressures, evidence base and users themselves.
End-to-end support for regulated digital health
From early ideas and funding applications through to build, deployment, monitoring and ongoing improvement.
Plan
Early technical scoping, product planning, funding application input and feasibility support.
Design
Co-design, user experience design, prototyping and testing with users and project teams.
Build
Secure software development, cloud hosting, infrastructure and technical documentation.
Deploy and support
Testing, deployment, monitoring, ongoing support, localisation and long-term improvement.
Support areas can include
- Early technical scoping and product planning
- Supporting research and funding applications
- Co-design with clinicians, researchers and lived-experience partners
- User experience design and prototyping
- Secure software development
- Cloud hosting and infrastructure
- Clinical safety and risk documentation
- Data protection and information governance
- Technical documentation for regulated products
- Testing, deployment and ongoing support
- Scaling, localisation and internationalisation
Built around co-design
Good medical device software cannot be created in isolation. It needs to reflect the needs of patients, clinicians, researchers, services and implementation partners.
During co-design, we look at what will make the product safe, usable and meaningful.
- Who the product is for
- What clinical or research problem it is solving
- How it will fit into existing services
- What users need to feel confident using it
- What data needs to be captured, stored or reported
- What risks need to be managed
- What evidence needs to be supported
- How the product may need to scale in the future
Compliance, safety and governance
Compliance is not something to bolt on at the end. Bitjam develops digital health software with safety, privacy and governance considered from the start.
Risk-aware from the start
We work with clinical safety specialists and project teams to help identify risks, document decisions and support safe deployment.
Clear documentation
We help teams think through the documentation, evidence and technical decisions needed for regulated digital health products.
Built for regulated settings
- MHRA regulation
- UKCA considerations
- GDPR
- DTAC
- DPIA processes
- DCB0129 clinical safety documentation
Built to protect trust
Digital health products often involve sensitive personal and clinical information, so security must be built into every stage.
Bitjam is ISO27001 certified for information security and is working towards ISO13485 for medical device quality management.
We design and develop with privacy, access control, secure hosting, data integrity and responsible information governance in mind.
Designed for real-world impact
A regulated digital health product only succeeds if people can use it.
Clear, accessible and appropriate
The design must work for real people, real services and real pressures, not just look good in a prototype.
Technology that feels supportive
We understand the importance of building tools that feel human, not cold or overly technical.
Why choose Bitjam?
Medical device software needs more than good development. It needs a team that understands clinical risk, regulation, data protection, technical documentation and the realities of healthcare delivery.
We help partners shape products properly from the start.
Bitjam combines secure software development with knowledge of MHRA expectations, UKCA considerations, DTAC, GDPR, DPIA and DCB0129 clinical safety processes, so software is not only well built, but safe, documented, usable and ready for real-world healthcare environments.
Let’s build something safe, useful and ready for impact
If you are developing a digital therapeutic, regulated medical device product or clinical software tool, Bitjam can help you move from idea to safe, usable and compliant delivery.
We work with research teams, healthcare organisations, universities and commercial partners to co-design digital health tools that are secure, ethical and ready for real-world impact.