132 - IEC 60601, A Life Without Standards, Evolution of Standards, Standards Development, and Emerging Technologies with Leo Eisner

On this episode, I was joined by Leo Eisner "IEC 60601 Guy", Founder of Eisner Safety Consultants. On this episode, Leo discusses:

• 00:56 Evolution of Industry Standards
• 02:00 The Impact of Standards on Medical Device Development
• 02:10 Standards and Regulatory Challenges
• 02:42 Standards in Medical Devices and Emerging Technologies
• 13:19 The Auditing Experience
• 17:59 The Challenge of Maintaining and Updating Standards
• 29:49 Concluding Thoughts and Where to Find More Information

Leo Eisner, founder and principal compliance and regulatory consultant of Eisner Safety Consultants (ESC), ESC provides the medical device industry with product safety compliance & regulatory support. Leo ensures his clients’ medical device compliance needs are met, provides his clients with practical assessments of their products and provides strategies & support to help them through the medical device product compliance maze based on his experience.

He has over 30 years of invaluable experience in the medical device industry. He worked at 3 notified bodies, and his career has spanned over 35 years of product safety certification test lab experience. He worked at 2 internationally recognized labs for 11 years. As an expert in the standards development process, Leo has been staying at the forefront of evolving medical device standards for over 20 years with standards such as the IEC 60601 series, ISO 15223, ISO 20417.

Links:

• Website: https://eisnersafety.com/
• Blog: https://eisnersafety.com/industry_news/ & Sign-up for newsletter on right side of
• page (1/2 way down)
• LinkedIn: linkedin.com/in/leoeisnersafetyconsultants
• Contact Us: https://eisnersafety.com/contact_eisner_safety/
• Schedule a call: https://eisnersafety.com/schedule-call/

• U.S. TAG 62D - https://www.aami.org/detail-pages/opentext-gateway-standards-committee/u.s.-tag-62d---electromedical-equipment-committee
• EV - WG 13 - Lens Removal and Vitrectomy Devices Working Group- https://www.aami.org/detail-pages/opentext-gateway-standards-committee/ev-wg-13---lens-removal-and-vitrectomy-devices-working-group
• JWG 9 Lens removal and vitrectomy devices for ophthalmic surgery - https://www.iec.ch/dyn/www/f?p=103:14:612205979307807::::FSP_ORG_ID,FSP_LANG_ID:2472,25