Software Compliance
Software Compliance
Driving Innovation with Confidence
Driving Innovation with Confidence
Software plays an increasingly central role in medical devices and scientific technologies. Whether your product includes embedded firmware, scientific algorithms, cloud‑based components, or standalone digital health functionality, you need a structured approach to software lifecycle management that aligns with IEC 62304 and regulatory expectations. TrueNorth helps teams build practical, proportionate software processes that integrate smoothly with your QMS and support safe, effective product development.
IEC 62304 can feel overwhelming, especially for small teams or organisations new to regulated development. TrueNorth breaks the standard down into clear, manageable activities that fit your product, your architecture, and your development style.
We help you establish:
software development planning
requirements and architecture documentation
risk‑based classification and controls
verification and validation activities
change and configuration management
release and maintenance processes
Everything is tailored to your team’s maturity and the complexity of your software.
Software compliance should not sit in a silo. We ensure your software lifecycle processes connect seamlessly with:
design controls
risk management
document control
change management
CAPA and continuous improvement
post‑market surveillance
This creates a unified, audit‑ready system that supports both hardware and software development.
TrueNorth works with organisations developing:
embedded firmware
scientific and analytical algorithms
cloud‑based or server‑side components
mobile or desktop applications
software as part of a device ecosystem
standalone software as a medical device (SaMD)
Each type has different regulatory expectations. We help you understand what applies and how to meet it efficiently.
We help you create clear, structured documentation that supports compliance without slowing development, including:
software development plans
requirements and architecture documents
risk assessments and traceability
verification and validation evidence
release notes and maintenance records
configuration and change control logs
Templates and structures are adapted to your tools — whether you use Atlassian, Git‑based workflows, cloud platforms, or hybrid systems.
Many teams struggle with:
unclear or inconsistent software documentation
difficulty mapping agile practices to regulatory expectations
gaps in traceability between requirements, risks, and tests
uncertainty about software classification
fragmented development and quality processes
legacy documentation that no longer fits the product
TrueNorth helps you build clarity, structure, and confidence — without unnecessary bureaucracy.
If you’re using Jira, Confluence, or other cloud tools, we can help you:
configure software workflows
integrate risk and traceability
align development tickets with design controls
structure documentation in Confluence
automate traceability where appropriate
This creates a modern, efficient environment that supports both compliance and rapid development.
Deep experience across software, quality, and regulatory roles
Practical, right‑sized processes that support innovation
Clear, structured documentation aligned with IEC 62304
Integration with your QMS and development tools
Fractional support model — ideal for teams needing only part-time support
Founder‑led expertise with no handoffs or unnecessary overhead
If you’re developing software as part of a regulated product, TrueNorth can help you build the structure, documentation, and processes needed to meet IEC 62304 and regulatory expectations — without slowing your team down.
Contact us to discuss your goals.