Navigating the New Rules of Medical Device Risk: ISO 14971:2019 Explained

This episode demystifies the latest version of the essential risk management standard, ISO 14971:2019. We explore the critical updates manufacturers must understand, from the expanded scope covering the entire device lifecycle to the proactive requirements for post-market activities. Learn about the key definition changes and the enhanced focus on benefit-risk analysis that are shaping global regulatory compliance and patient safety. Key Questions: • What prompted the update from the 2007 version to ISO 14971:2019? • How does the standard define "benefit," "state of the art," and "reasonably foreseeable misuse"? • What is the significance of the shift to "benefit-risk" analysis? • How have requirements for post-production monitoring changed? • What is "overall residual risk" and how must it be evaluated? • Why is the entire device lifecycle now a central focus of risk management? • How does ISO 14971:2019 align with major regulations like the EU MDR? • What does it mean to have a "proactive" approach to risk management? Ready to turn these insights into your competitive edge? Pure Global’s regulatory experts guide MedTech companies through every step of 30+ markets worldwide. Explore how we can accelerate your market entry at https://pureglobal.com or email [email protected] for tailored support.