Healthcare/Medical Device Software Development
Medical device software development
Software for medical devices and SaMD, engineered to standards, with the validation and documentation regulated products demand.
In short
Medical device software development is the engineering of software that is part of, or is itself, a medical device, including Software as a Medical Device (SaMD), embedded device software and the apps and cloud that connect to them. Noseberry is a medical software development company that builds this software to recognised engineering standards, with validation, traceability and FDA-oriented documentation support. We act as your technical implementation partner and work alongside your regulatory experts; we do not provide legal or regulatory consultancy ourselves.
Who it is for
Medical device manufacturers
Building or modernising device software and companion apps.
SaMD and digital-therapeutics companies
Whose product is software that performs a medical function.
HealthTech startups
Whose product may meet the definition of a medical device and needs to be built correctly from the start.
What we build
Capability
What it does
Why it matters
SaMD software
Software that performs a medical function
Built to the risk and quality bar it requires
Embedded and device software
Software on or controlling the device
Reliable, safe operation
Connected apps and cloud
Companion apps and secure data pipelines
The device fits the wider ecosystem
Interoperability
HL7, FHIR and device-data integration
Data reaches the EHR and care team
Validation and traceability
Testing, verification and requirement traceability
Evidence for quality and safety
FDA-oriented documentation support
Technical documentation for your submissions
Speeds your regulatory work
Cybersecurity
Secure design and lifecycle controls
Protects patients and data
How we build regulated device software
Classify and scope
Understand the intended use and likely risk class, with your regulatory team.
Design under quality controls
Requirements, risk management and architecture.
Build to standards
Engineering with traceability from requirement to test.
Verify and validate
Testing and evidence appropriate to the risk.
Document
FDA-oriented technical documentation to support your submission.
Maintain safely
Controlled change, monitoring and cybersecurity across the lifecycle.
Where the boundary sits
We are the technical implementation partner. We build the software, validate it and prepare the technical documentation your submission needs. Your regulatory and quality experts own the regulatory strategy, classification decisions and the submission itself. When qualified regulatory specialists are involved, we work hand in hand with them.
Outcomes that matter
Right the first time
Software built to the quality bar from the start, not retrofitted.
Faster submissions
Documentation and traceability your regulatory team can use.
Safe by design
Risk management and cybersecurity across the lifecycle.
Connected
Device data that reaches the EHR and care team.
Why Noseberry
A medical software development company with a decade of regulated-data experience across 250+ products in 20+ countries, combining engineering discipline with validation and documentation. Standards-based, secure by design, and fully owned by you with no lock-in.
How our services power healthcare
The full Noseberry stack, applied to healthcare.
AI Solutions
Clinical documentation AI, prior-authorisation automation, predictive risk models and imaging support, built human-in-the-loop and validated.
Data and Analytics
FHIR data platforms, population-health and operational analytics, and predictive models that turn scattered clinical data into decisions.
Cloud and DevOps
HIPAA-aligned cloud architecture, secure migration and DevSecOps for regulated healthcare workloads that cannot go offline.
Digital Engineering
The systems themselves: EHR and FHIR integration, custom healthcare platforms, telemedicine and patient apps that connect care.
User Experience
Clinician and patient interfaces designed for real workflows and real patients, accessible, multilingual and safe to act on.
Growth, for health tech
If you build healthcare or health-tech products, our Product Growth and Growth Marketing teams help you launch and scale.
Medical device software development, answered.
It is the engineering of software that is part of a medical device or is itself a medical device (SaMD), including embedded device software and the connected apps and cloud around it, built to appropriate quality and safety standards.
SaMD is software intended to perform a medical function without being part of a hardware device, for example software that analyses data to support diagnosis or treatment. It is regulated according to its risk.
We provide FDA-oriented technical documentation and validation to support your submission, and we work alongside your regulatory experts. We are the technical implementation partner; we do not provide legal or regulatory consultancy ourselves.
Through requirements management, risk management, verification and validation, requirement-to-test traceability, and cybersecurity controls across the lifecycle.
Yes. We build HL7 and FHIR interoperability so device data reaches the EHR and care team. See our EHR and FHIR integration services.
That depends on its intended use and is a regulatory determination your experts make. We build correctly for either outcome and align the engineering to the risk class you confirm.
Build device software to the right bar.
Book a free 30-minute call and we will scope your device software and how we work with your regulatory team.
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