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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 ๐ถ๐ป๐๐ถ๐ฑ๐ฒ๐ฟ ๐ฐ๐ผ๐บ๐บ๐ถ๐๐๐ฒ๐ฒ ๐บ๐ฒ๐บ๐ฏ๐ฒ๐ฟ that wrote portions of ๐๐๐ ๐ฒ๐ฌ๐ฒ๐ฌ๐ญ-๐ญ, ๐ฒ๐ฑ ๐ฏ.๐ฎ ๐๐บ๐ฒ๐ป๐ฑ๐บ๐ฒ๐ป๐๐ 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 “๐๐๐ ๐ฒ๐ฌ๐ฒ๐ฌ๐ญ ๐๐๐” 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.
Whatโs The Relationship of Updated IMDRF N47 & N52 to IEC 60601-1, 4th ed?
๐ฅ๐๐ฅ๐๐๐๐๐ก๐ ๐ก๐๐ช๐ฆ๐ฅ ๐๐ ๐๐ฅ๐ ๐ก๐ฐ๐ณ & ๐ก๐ฑ๐ฎ recently updated to ๐๐ฑ๐ถ๐๐ถ๐ผ๐ป ๐ฎ โ ๐ช๐ต๐ฎ๐โ๐ ๐๐ต๐ฒ ๐ฟ๐ฒ๐น๐ฎ๐๐ถ๐ผ๐ป๐๐ต๐ถ๐ฝ ๐๐ผ ๐๐๐ ๐ฒ๐ฌ๐ฒ๐ฌ๐ญ-๐ญ, ๐ฐ๐๐ต ๐ฒ๐ฑโ
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.
๐๐ ๐๐ฅ๐ ๐ฝ๐๐ฏ๐น๐ถ๐๐ต๐ฒ๐ฑ two Final documents on ๐ฎ๐ฒ ๐๐ฝ๐ฟ๐ถ๐น ๐ฎ๐ฌ๐ฎ๐ฐ, 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