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What Standards Apply to My Device? Podcast #383

𝗪𝗵𝗮𝘁 𝗦𝘁𝗮𝗻𝗱𝗮𝗿𝗱𝘀 𝗔𝗽𝗽𝗹𝘆 𝘁𝗼 𝗠𝘆 𝗗𝗲𝘃𝗶𝗰𝗲? Podcast with one of the best MedTech podcasters Etienne Nichols – Greenlight Guru’s very own

𝗞𝗲𝘆 𝗧𝗼𝗽𝗶𝗰𝘀:‼️
• Why standards like IEC60601 are crucial for medical device development
• Steps for identifying proper standards for your product
• How to integrate standards into your design process
• Mistakes & consequences of ignoring standards
• Tools for staying updated on changing standards & regulations
• How startups can navigate standards with limited resources

How to ID Applicable Standards – Combinate Podcast

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

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.

Watch Free Webinar IEC 60601 Amendments & CB Scheme

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”

Leo Eisner the “IEC 60601 Guy” co-presenter in BSI Webinar

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.