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In this episode of the Global Medical Device Podcast, Etienne Nichols sits down with Leo Eisner, founder of Eisner Safety Consultants and a leading voice in IEC 60601 standards development. We unpack the upcoming revisions to IEC 60601, 4th ed.,
Free Presentation in London Oct 7 On IEC 60601-1, 4th Ed. and More with Leo Eisner and Ian Sealey
Whatโs on the menu๐ฐ?
Where are we headed with 4th Ed.?
Structure changes;
Project timeline: and
Critical documents
Leo Eisner, the โIEC 60601 Guyโ, of Eisner Safety Consultants will be your guide
What to do in the meantime?
Select applicable and normative standards for testing; and
How to set up a solid future-proof test plan
Ian Sealey of Vertexian will explain it
Clayton Hotel Chiswick
Arrive 5:15 PM
Starts 5:30 PM sharp
Ends 8:45 PM
Networking and meet for drinks afterwards
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.
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
2 February 2022 On 1 February 2022 the Gov.UK website updated their Guidance on Using the UKNI Marking. It was originally published on 31 December 2020. This is guidance for placing goods on the Northern Ireland market. The UKNI mark