Quality Risk Management (QRM), driven by international standards such as ISO 14971 and ICH Q9, is an essential resource for maintaining product quality, achieving regulatory compliance, ensuring patient safety, and promoting continuous improvement. The fundamental principles of QRM are imperative throughout the product lifecycle, and by implementing a structured framework, organizations can effectively assess, manage, and mitigate risks. Fostering a strong QRM culture is critical because it encourages proactive risk identification, enhances cross-functional collaboration, and upholds a commitment to excellence. By implementing QRM early in the product development process, organizations can transform compliance from a perceived challenge into a strategic advantage, fostering a culture focused on collaboration, risk-informed decision-making, and a steadfast dedication to patient well-being and customer success.
