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Join me, Leonard (Leo) Eisner, the “IEC 60601 Guy”,
in a conversation with Subhi Saadeh of Combinate Podcast
as we look at how to assess applicable standards for medical and combination devices and a few highlights on IEC 60601-1, 4th ed. in Combinate Podcast 148
We are thrilled to announce three incredibly talented individuals joining the Eisner Safety Consultants Team to support your needs.
Beat Keller’s expertise comprises the IEC 60601 series, software, and regulatory/quality. In the regulatory/quality area his focus is on EU MDR, Swiss MedDO and UK MDR.
Lisa Donlon’s expertise encompasses device regulatory/submissions and quality. Her focus is on EU MDR, clinical support, and the U.S.
Dan Modi’s expertise spans the IEC 60601 Series, EMC, design quality, device submissions/regulatory – EU MDR, U.S., India, China, Brazil, Japan and more.
We have strengthened our team to support your needs so please feel free to schedule a meeting to discuss your needs or contact us.
Learn from an 𝗶𝗻𝘀𝗶𝗱𝗲𝗿 𝗰𝗼𝗺𝗺𝗶𝘁𝘁𝗲𝗲 𝗺𝗲𝗺𝗯𝗲𝗿 that wrote portions of 𝗜𝗘𝗖 𝟲𝟬𝟲𝟬𝟭-𝟭, 𝗲𝗱 𝟯.𝟮 𝗔𝗺𝗲𝗻𝗱𝗺𝗲𝗻𝘁𝘀 and is involved in the development of the Fourth Edition of IEC 60601-1. If you want to learn about these updates to the standard and the IEC 60601 Amendments Project – You’re in luck – Leonard (Leo) Eisner the “𝗜𝗘𝗖 𝟲𝟬𝟲𝟬𝟭 𝗚𝘂𝘆” from Eisner Safety Consultants partnered with Holly Rossington of BSI to present the webinar “Leveraging the CB Scheme: A Guide for North American Medical Device Manufacturers”
Webinar: Leveraging the CB Scheme: A Guide for North American Medical Device Manufacturers
When: Tuesday, June 25, 2024
Time: 11:00 a.m – 12:00 p.m. EDT
About the Event: Join BSI & Leo Eisner for an insightful webinar that explores how North American medical device manufacturers can harness the power of the CB Scheme to enhance their global market access. Leo the “IEC 60601-1 Guy” will be presenting on the significant updates introduced in the latest edition of IEC 60601-1 Ed. 3.2, which will impact medical device manufacturers.
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