About
About
At TrueNorth, our mission is to provide expert consultancy services tailored to the medical device sector. We are dedicated to helping companies implement and maintain robust business processes in Quality Management Systems (QMS), ensuring quality and compliance with ISO 13485:2016 and applicable regulations.
Our consultancy was founded with a passion for bridging the gap between academic research and commercial product development. With first-hand experience in transferring technologies from academic concepts and R&D to regulated product development, we understand the challenges and opportunities in the medical device industry.
Experience: With a decade of postdoctoral R&D experience and over 20 years in the medical device sector, we bring a wealth of knowledge and expertise to every project. Our diverse roles in product development, operations, quality, and regulatory affairs ensure comprehensive and effective solutions.
Commitment to Quality: We are committed to ensuring the highest standards of quality and compliance in everything we do.
Client-Centered Approach: We work closely with our clients to understand their unique needs and provide tailored solutions that drive success.
Innovative Solutions: We leverage advanced tools and technologies to create efficient, effective, and compliant business processes.