Navigating the New Rules of Medical Device Risk: ISO 14971:2019 Explained
Medical Device Global Market Access · Pure Global
July 25, 20253m 27s
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Show Notes
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.