Episode Details

This episode delves into the critical cybersecurity standard IEC 81001-5-1, published in 2021. We explore its origins, its comprehensive lifecycle approach to securing health software, and its growing importance for regulatory approval in key global markets like the EU, US, and Japan. Manufacturers will learn what the standard requires and why compliance is no longer optional but a strategic advantage. Key Questions: • What is IEC 81001-5-1 and why was it created? • How does this standard change the approach to software development and maintenance? • Does this standard apply only to medical devices, or is the scope broader? • What are the core requirements, from threat modeling to post-market surveillance? • How does the standard build upon existing frameworks like IEC 62304? • What is the regulatory status of IEC 81001-5-1 in the EU and the US? • Why is compliance becoming a non-negotiable for global market access? • What are the risks of ignoring this new cybersecurity benchmark? 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 info@pureglobal.com for tailored support.