Fractional regulatory and quality support for organisations developing medical devices and scientific technologies.
Startups, spinouts, and growing companies face steep regulatory expectations. TrueNorth helps you build practical, compliant systems that support innovation, meet ISO 13485 and regulatory requirements, and scale efficiently with your team.
Developing a regulated product is complex, but your processes don’t need to be.
TrueNorth supports early‑stage and scaling teams in establishing or strengthening their Quality Management System, aligning with ISO 13485:2016, and meeting applicable regulatory expectations. We work with any QMS approach — from lightweight, paper‑based systems to fully electronic platforms — and provide practical guidance that fits the size and maturity of your organisation. Where appropriate, we also help teams modernise their workflows using cloud‑based tools or AI‑enabled automation to reduce overhead and maintain audit‑ready documentation.
Whether you’re a university spinout building your first prototype or an established company needing clarity to move forward, we provide the structure and momentum to keep you compliant and investor‑ready.
Build a practical, scalable Quality Management System aligned with ISO 13485.
Startups, spinouts, and growing teams need a QMS that supports innovation rather than slowing it down. TrueNorth helps you design and implement right‑sized processes, documentation, and controls that meet regulatory expectations and grow with your organisation. Whether you’re starting from scratch or strengthening an existing system, we provide clear, structured guidance that fits your stage of development.
Modern, efficient workflows using cloud‑based tools that keep teams aligned.
Many organisations benefit from moving away from paper‑based or fragmented systems. We help you design and configure cloud‑based processes — using platforms such as Atlassian or other electronic QMS tools — to streamline documentation, improve traceability, and reduce overhead. Where appropriate, AI‑enabled automation can further support small teams in maintaining audit‑ready records with minimal effort.
Support for software lifecycle processes aligned with IEC 62304 and related standards.
Whether your product includes embedded software, scientific algorithms, or standalone digital health functionality, we help you establish the documentation, lifecycle controls, and risk management practices needed for compliance. Our approach is practical and proportionate, ensuring your software processes integrate smoothly with your broader QMS and product development activities.
Internal audits that provide clarity, identify gaps, and support continuous improvement.
We conduct independent internal audits to assess compliance with ISO 13485, IEC 62304, and your own internal procedures. Findings are presented clearly and constructively, helping your team understand what’s working, where improvements are needed, and how to prepare confidently for external audits or regulatory submissions.
TrueNorth Services Ltd is led by Dr Alasdair Christie, a regulatory architect with over 30 years’ experience in the medical device and scientific technology sectors. With a background spanning academic research, product development, operations, quality, and regulatory affairs, Al specialises in helping organisations build practical, compliant, and scalable business processes aligned with ISO 13485:2016 and applicable regulations.
Clients work directly with the expert—ensuring clarity, efficiency, and solutions tailored to their stage of growth.
Fractional regulatory and quality support
Ideal for early‑stage teams and growing companies needing ongoing guidance without a full‑time hire.
Typical engagements: 1–4 days per month, rolling basis.
Whether you’re a startup, spinout, or established team needing clarity and momentum, TrueNorth provides fractional regulatory and quality support that fits your stage of growth.