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About TrueNorth

Consulting Services for the Healthcare and Medical Devices Sector We provide consultancy services tailored to the medical device sector, helping companies implement and maintain robust business processes in Quality Management Systems (QMS) that meet ISO 13485:2016 and applicable regulations. With TrueNorth, you can navigate the complexities of the medical device industry and achieve success. Our Services Include: - Startups and University Spinouts: Leveraging first-hand experience in transferring technologies from academic concepts and R&D to regulated product development. Design and development, production, quality & regulatory compliance, and global market release. - QMS Implementation: Assisting startups and established businesses alike in setting up and maintaining compliant Quality Management Systems. - Design Control: Guiding companies through design control processes to ensure efficiency, compliance with standards and regulations, and seamless market access. - Software Compliance: Implementing processes and technical documentation for software development in line with IEC 62304, recognizing that software is a cornerstone of modern healthcare technologies. - Transition to MDR and IVDR: Providing support for a seamless transition, including gap analysis, transition plans, and supporting updates to QMS and Technical Documentation to meet regulatory requirements. - Audits: Conducting thorough audits to identify gaps, highlight areas for improvement, and ensure compliance with industry standards and regulations. - eQMS implementation: Creating Jira and Confluence-based electronic Quality Management Systems (eQMS) that operate end-to-end across all business functions, ensuring seamless integration and efficient process management.

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