Software Compliance
Software Compliance
Driving Innovation with Confidence
Driving Innovation with Confidence
Modern healthcare technologies are powered by software. At TrueNorth, we recognise the critical role that software plays in transforming medical devices, improving patient outcomes, and addressing complex healthcare challenges. Our Software Compliance services are designed to empower your team with the knowledge, tools, and processes needed to navigate standards and regulations with confidence, ensuring your software is safe, effective, and compliant.
We work alongside you as trusted advisors, offering guidance and support at every step. Whether you’re establishing a software development lifecycle or enhancing existing processes, our goal is to equip you with the expertise and frameworks necessary to take ownership of compliance. You’ll have access to our experience, but the control remains firmly in your hands.
We help you understand and implement processes aligned with essential standards governing Software as a Medical Device (SaMD), including:
ISO 13485:2016: Quality Management System requirements for regulatory purposes.
ISO 14971:2019: Risk management principles tailored for medical devices.
IEC 62304: Software lifecycle processes for medical device development and maintenance.
IEC 82304-1: Product standard for health software, complementing IEC 62304.
IEC 62366-1: Usability engineering principles to enhance safe and effective software use.
IEC 81001-5-1: Cybersecurity standards addressing medical devices and health IT software.
Software Development Life Cycle (SDLC): Advising on how to structure and document lifecycle processes in compliance with IEC 62304, from planning to maintenance.
Risk Management for Software: Guiding you in applying ISO 14971 principles to identify and mitigate software-related risks effectively.
Cybersecurity Compliance: Supporting the integration of cybersecurity measures as per IEC 81001-5-1, tailored to your software’s needs.
Usability Engineering: Advising on how to incorporate IEC 62366-1 usability principles to improve user experience and safety.
Verification and Validation (V&V): Providing strategies and best practices for setting up robust V&V processes in line with IEC 62304.
Technical Documentation: Helping you create and maintain documentation to support regulatory submissions, including software requirements, designs, and test records.
Support, Not Dependence: We empower your team to take ownership, ensuring you build the skills and confidence to manage compliance independently.
Expert Insights: With decades of experience, we provide actionable guidance tailored to your specific needs.
Efficient Frameworks: Our advisory approach streamlines compliance without unnecessary complexity, helping you focus on innovation.
Take control of software compliance with our expert guidance and support. Contact TrueNorth Services Ltd to learn how we can help you develop efficient, compliant software for modern healthcare technologies.