About
About
At TrueNorth, our mission is to help organisations developing medical devices and scientific technologies build the processes, systems, and documentation needed to meet ISO 13485 and regulatory expectations—without slowing innovation. We specialise in supporting startups, university spinouts, and established companies who need clarity, structure, and practical guidance to move forward confidently.
TrueNorth was founded by Al Christie, a regulatory architect and systems specialist with over 20 years’ experience in the medical device sector and a decade of postdoctoral R&D. With first-hand experience transferring technologies from academic research into regulated commercial products, Al understands the unique challenges faced by early-stage teams and growing organisations.
This blend of scientific, operational, quality, and regulatory experience enables TrueNorth to provide solutions that are both compliant and grounded in real-world product development.
Deep Experience — Broad expertise across R&D, product development, operations, quality, and regulatory affairs ensures a holistic approach to compliance and process design.
Practical, Right-Sized Systems — We help teams build QMS structures that fit their size, maturity, and goals—whether paper-based, hybrid, or fully electronic.
Innovative Tools — We leverage modern cloud platforms and, where appropriate, AI-enabled automation to streamline documentation, reduce overhead, and maintain audit-ready systems.
Client-Centred Approach — Every engagement is tailored. You work directly with the expert, ensuring clarity, continuity, and solutions that support your organisation’s growth.
Commitment to Quality — We are dedicated to helping teams build robust, scalable processes that stand up to scrutiny and support long-term success.