Product definition & architecture
Intended users, use environments, product requirements, system boundaries, architecture and technical choices aligned with clinical and regulatory risk.
Medical Device Software Development
Medical device software development.
We design, build, remediate and maintain SaMD and SiMD products with the software lifecycle evidence regulators expect. Product engineering and design controls move together, so the submission does not become a reconstruction exercise.
Selected clients
Healthcare teams we have supported
Scope and deliverables
Software development and documentation included in the service.
The exact scope follows your intended use, software safety classification, architecture and market. We can own the full build or strengthen the areas your team cannot cover internally.
UX for clinical workflows
Interfaces designed around users, use-related risk and workflow reality, with human-factors considerations built into requirements and validation.
Full-stack product development
Frontend, backend, cloud, APIs, data pipelines and integrations implemented as production software—not a research prototype.
IEC 62304 lifecycle evidence
Software development planning, requirements, architecture, detailed design where needed, traceability, configuration and release records.
Verification & validation
Risk-based test strategy, unit and integration testing, system verification, validation support and objective evidence linked to requirements.
Secure development & maintenance
Security architecture, dependency governance, vulnerability handling, anomaly management, change assessment and post-market software maintenance.
Ways to work together
Choose the support your team needs.
End-to-end product partner
We take the product from requirements and architecture through implementation, verification, release and submission support.
Specialist team augmentation
Medical-device software engineers join your team, work within your QMS and close defined technical or documentation gaps.
Prototype-to-product remediation
We assess existing software, preserve what is sound and remediate architecture, testing, cybersecurity and lifecycle evidence.
How it works
Our process.
- 1
Define
Clarify intended use, users, claims, system boundaries, markets and software safety classification.
- 2
Plan
Map architecture, risks, design controls, cybersecurity and evidence into an executable development plan.
- 3
Build & verify
Develop in controlled increments while requirements, risks, code, tests and decisions remain traceable.
- 4
Release & maintain
Complete release evidence, support the submission and manage anomalies and changes after launch.
Regulations, standards and guidance considered
IEC 62304ISO 14971IEC 62366-1ISO 13485 design controlsFDA QMSRFDA software guidanceFDA cybersecurity guidanceDICOM / HL7 / FHIR
Frequently asked questions
Questions teams ask before they begin.
Can you take over an existing prototype?+
Yes. We begin with a focused assessment of architecture, code quality, requirements, testing, dependencies and documentation. The goal is to preserve defensible work and create a proportionate remediation plan rather than automatically rebuilding the product.
Can your developers work within our QMS?+
Yes. We can follow your approved procedures, templates, review controls and tooling. If your software procedures are incomplete, our regulatory team can identify the gaps and help establish a workable lifecycle before development accelerates.
Do you only develop Software as a Medical Device?+
No. We support both SaMD and software that forms part of a hardware medical device, often called SiMD. The development and documentation strategy is tailored to the system architecture, safety classification and applicable market requirements.
Do you build AI/ML-enabled medical devices?+
We can support AI-enabled products where software engineering, data pipelines, model integration, performance evidence and lifecycle controls must work together. The exact AI/ML scope is agreed after reviewing the intended use, available data and validation needs.
What happens after the first release?+
Medical-device software needs controlled maintenance. We can support anomaly evaluation, vulnerability monitoring, dependency updates, change impact assessments, regression testing, new releases and the regulatory assessment of significant product changes.
Related expertise
FDA Regulatory Consulting
Choose the pathway, define the evidence and prepare the FDA submission.
FDA Cybersecurity
Build the cybersecurity evidence expected for a connected medical device submission.
Concept to Cleared Device
Combine software development, evidence and FDA execution in one integrated programme.
Start with the product you have