Free Presentation in London Oct 7 On IEC 60601-1, 4th Ed. and Meet with Leo Eisner in London

Free Presentation in London Oct 7 On IEC 60601-1, 4th Ed. and Meet with Leo Eisner in London

Free Presentation in London Oct 7 On IEC 60601-1, 4th Ed. and More with Leo Eisner and Ian Sealey

Whatโ€™s on the menu๐Ÿฐ?

Where are we headed with 4th Ed.?
Structure changes;
Project timeline: and
Critical documents

Leo Eisner, the โ€œIEC 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

Welcome 3 Global Experts to the Eisner Safety Consultants Team

Welcome 3 Global Experts to the Eisner Safety Consultants Team

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.

Whatโ€™s The Relationship of Updated IMDRF N47 & N52 to IEC 60601-1, 4th ed?

Whatโ€™s The Relationship of Updated IMDRF N47 & N52 to IEC 60601-1, 4th ed?

Whatโ€™s The Relationship of Updated IMDRF N47 & N52 to IEC 60601-1, 4th ed?

๐Ÿ’ฅ๐—•๐—ฅ๐—˜๐—”๐—ž๐—œ๐—ก๐—š ๐—ก๐—˜๐—ช๐—ฆ๐Ÿ’ฅ ๐—œ๐— ๐——๐—ฅ๐—™ ๐—ก๐Ÿฐ๐Ÿณ & ๐—ก๐Ÿฑ๐Ÿฎ recently updated to ๐—˜๐—ฑ๐—ถ๐˜๐—ถ๐—ผ๐—ป ๐Ÿฎ โ€“ ๐—ช๐—ต๐—ฎ๐˜โ€™๐˜€ ๐˜๐—ต๐—ฒ ๐—ฟ๐—ฒ๐—น๐—ฎ๐˜๐—ถ๐—ผ๐—ป๐˜€๐—ต๐—ถ๐—ฝ ๐˜๐—ผ ๐—œ๐—˜๐—– ๐Ÿฒ๐Ÿฌ๐Ÿฒ๐Ÿฌ๐Ÿญ-๐Ÿญ, ๐Ÿฐ๐˜๐—ต ๐—ฒ๐—ฑโ“

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.

๐—œ๐— ๐——๐—ฅ๐—™ ๐—ฝ๐˜‚๐—ฏ๐—น๐—ถ๐˜€๐—ต๐—ฒ๐—ฑ two Final documents on ๐Ÿฎ๐Ÿฒ ๐—”๐—ฝ๐—ฟ๐—ถ๐—น ๐Ÿฎ๐Ÿฌ๐Ÿฎ๐Ÿฐ, 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

Regulatory Updates – January 2022

Regulatory Updates – January 2022

Regulatory Update – January 2022 Index I have 4 Regulatory updates (US (2), England, Scotland & Wales (1), EU 1)) for you that are full of great information. Below is a mini index so you can jump around the world