Kenn Milton "Quality Management in Life Science Companies", Copenhagen University, SUND Hub

This video explores the critical role of Quality Management Systems (QMS) in life science companies, specifically focusing on medical devices. The speaker details the classification of medical devices by risk, outlining how these classifications dictate the necessary level of documentation and regulatory compliance. Throughout the video, the importance of a robust QMS for ensuring patient safety, achieving market access, and enhancing company valuation is emphasized, particularly highlighting the shift towards electronic QMS (eQMS) for improved efficiency and audit readiness.

Key Takeaways:

• Risk-Based QMS Requirements: Medical devices are categorized into different risk classes (Class I to III), which determine the extent of documentation and QMS implementation required for regulatory approval and market access. While not always mandated for Class I, a QMS is strongly recommended for all devices.
• Documentation and Qualification are Paramount: The fundamental principles of QMS dictate that "if it's not documented, it hasn't happened; if it's not signed, it's not documented." Furthermore, all personnel involved must be adequately qualified through education, experience, and training, with documented evidence to support their competence.
• Current Regulatory Focus Areas: Regulators are increasingly scrutinizing risk assessment and post-market surveillance (PMS). Companies must proactively identify, evaluate, control, and accept risks, while also implementing both proactive (e.g., control groups) and reactive (e.g., incident/complaint trending) PMS activities to continuously monitor product safety and performance.
• Benefits of Electronic QMS (eQMS): Transitioning from paper-based systems to an eQMS offers significant advantages, including electronic signatures, streamlined documentation management, continuous improvement tracking, and simplified audit processes, transforming audits into collaborative conversations rather than stressful examinations.
• Early QMS Implementation is Crucial: Introducing a QMS from the very beginning of product development, rather than as an afterthought, ensures "quality by design." This approach saves significant rework, provides a clear roadmap for compliance, and helps secure the necessary data stamps and sequence of events expected by auditors.
• Strategic Value of QMS: Beyond compliance, a well-implemented QMS is a strategic asset. It is essential for market access (e.g., CE marking, FDA approval), significantly increases a company's valuation for potential acquisition, and provides individuals with valuable experience and qualifications that enhance career prospects in the life sciences industry.