In this episode of MedTech Global Insights, we explore the new cornerstone of medical device security, the IEC 81001-5-1 standard. As healthcare technology becomes increasingly connected, the risk of cyber threats poses a significant danger to patient safety and can create major barriers to market entry. We break down what this standard means for manufacturers and why it's a critical component for regulatory approval in major markets like the U.S. and Europe. We discuss the standard's lifecycle approach, which integrates security into every phase of product development, from design and threat modeling to post-market surveillance. Learn how IEC 81001-5-1 aligns with the stringent expectations of the FDA and the EU MDR, and how compliance is no longer optional but essential for global success. Consider this scenario: a company's new AI-powered diagnostic software is rejected by the FDA during premarket submission. The reason? A vulnerability in an open-source component that could potentially expose patient data. This single oversight leads to a six-month delay, significant remediation costs, and loss of investor confidence. This episode explains how adopting IEC 81001-5-1 from day one would have prevented this, by mandating a secure software supply chain and robust vulnerability management plan. Key Takeaways: * Why are traditional IT security measures insufficient for protecting modern medical devices? * What is a Secure Product Development Framework and how does it change your development process? * How can threat modeling in the design phase prevent a costly product recall later? * What specific documentation does the FDA now require to avoid a "Refuse to Accept" decision on cybersecurity grounds? * How does IEC 81001-5-1 help you meet the EU MDR's requirements for IT security and data protection? * What is your responsibility for patching vulnerabilities after your device is already on the market? * How can you ensure third-party software components don't introduce critical security risks into your product? For more information, contact us at [email protected] or visit https://pureglobal.com/.