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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…
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