Software Engineering & Product Development
Engineering decisions determine regulatory outcomes. We help teams define, architect and build regulated healthcare software that is technically robust, scalable and designed for approval from the outset.
Organisations we support.
- SaMD and digital health companies developing a first regulated product.
- Established manufacturers scaling software capability or moving to a platform model.
- Teams building AI or machine-learning features into regulated products.
- Organisations that have inherited or acquired software they now need to place on the market.
What typically goes wrong.
- Architecture that cannot evidence the separation, control or traceability regulators expect.
- Requirements written after the code, leaving verification impossible to trace.
- Third-party and open-source components used without SOUP justification or an SBOM.
- AI and ML functionality developed without a defensible development and validation approach.
- Inherited codebases with no lifecycle records, making regulatory submission unworkable.
The work we perform.
Product definition & strategy
Defining intended use, product scope and the technical strategy that supports it.
Software architecture
Architecture and design that supports safety, maintainability, reuse and regulatory separation.
IEC 62304 lifecycle frameworks
Practical lifecycle processes your engineers will actually follow, sized to your safety classification.
Software engineering
Hands-on development and technical delivery alongside your team, not just advice.
Requirements & traceability
Requirement structures and traceability models linking intended use, design, risk and verification.
Verification & validation
V&V strategy, planning and evidence that stands up to independent review.
SOUP, OSS & SBOM
Identification, justification and ongoing management of third-party and open-source software.
AI & ML systems
Development and validation approaches for AI-enabled healthcare products.
Inherited software remediation
Reconstructing architecture, requirements and evidence for software you didn't originally build.
What you might receive.
Scope is agreed per engagement — the outputs below are typical examples.
Because our engineers work alongside regulatory specialists, architecture and requirements are shaped by what will eventually need to be evidenced. The result is documentation that is a by-product of development rather than a reconstruction exercise months later.
Building something regulated?
Tell us where your product is today and we'll tell you where the engineering risk sits.