Join me for an Interactive Workshop Identifying Standards, Guidances, & Turn Standards into Your Competitive Advantage @ 10X

Join me for an Interactive Workshop Identifying Standards, Guidances, & Turn Standards into Your Competitive Advantage @ 10X

Join me, Leo Eisner, The IEC 60601 Guy, as I lead an interactive and fun workshop at the 10X Medical Device Conference in Newport Beach, Ca on May 7 – 8, 2025. Turn Medical Device Standards into Your Competitive Advantage,

ISO 20417, 2nd DIS Breaking News from Tokyo Meeting 📣📣

ISO 20417, 2nd DIS Breaking News from Tokyo Meeting 📣📣

👉 ISO TC 210 WG2 met in Tokyo, Japan 🇯🇵 on 4 – 5 March 2025. 👉 WG2 meeting focused primarily on resolving the National Committees (NCs) comments received on the ISO/DIS 20417, 2nd ed. Changes proposed: 👉 Add reference

What’s The Relationship of Updated IMDRF N47 & N52 to IEC 60601-1, 4th ed?

What’s The Relationship of Updated IMDRF N47 & N52 to IEC 60601-1, 4th ed?

What’s The Relationship of Updated IMDRF N47 & N52 to IEC 60601-1, 4th ed?

💥𝗕𝗥𝗘𝗔𝗞𝗜𝗡𝗚 𝗡𝗘𝗪𝗦💥 𝗜𝗠𝗗𝗥𝗙 𝗡𝟰𝟳 & 𝗡𝟱𝟮 recently updated to 𝗘𝗱𝗶𝘁𝗶𝗼𝗻 𝟮 – 𝗪𝗵𝗮𝘁’𝘀 𝘁𝗵𝗲 𝗿𝗲𝗹𝗮𝘁𝗶𝗼𝗻𝘀𝗵𝗶𝗽 𝘁𝗼 𝗜𝗘𝗖 𝟲𝟬𝟲𝟬𝟭-𝟭, 𝟰𝘁𝗵 𝗲𝗱❓

IMDRF N47 & N52 both have been updated which will support Regulatory Submissions and Compliance Testing for the future of the IEC 60601 series including IEC 60601-1, 4th edition.

𝗜𝗠𝗗𝗥𝗙 𝗽𝘂𝗯𝗹𝗶𝘀𝗵𝗲𝗱 two Final documents on 𝟮𝟲 𝗔𝗽𝗿𝗶𝗹 𝟮𝟬𝟮𝟰, both to Version 2:
N47 Essential Principles of Safety and Performance of Medical Devices & IVD Medical Devices, and N52 Principles of Labeling for Medical Devices and IVD Medical Devices