In this episode, Etienne Nichols talks with Leo Eisner, renowned as the "IEC 60601 Guy" and founder of Eisner Safety Consultants, about the importance of selecting the right standards in medical device development.
Leo shares his journey into the world of medical device standards, offering a detailed look into the role that standards play in ensuring product safety and regulatory compliance. They dive deep into IEC 60601, ISO 15223, and the regulatory landscape across global markets.
Leo also shares actionable advice on avoiding pitfalls, prioritizing standards, and ensuring compliance to bring safe, effective devices to market without delays.
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Consensus Standards – These are standards developed by experts in the field and recognized by regulatory bodies like the FDA. While they are technically voluntary, using them greatly simplifies the regulatory approval process.
Greenlight Guru - Quality Management System & Electronic Data Capture solutions built by Medtech professionals for MedTech professionals.
Leo Eisner on LinkedIn – Connect with Leo for expert insights on compliance and regulatory standards.
IEC Standards – The international standard for the safety of electrical medical equipment.
ISO 15223 – Standard for symbols to be used with medical device labeling.
MedBoard – A platform for regulatory intelligence, tracking medical device standards.
Etienne Nichols on LinkedIn – Connect with the podcast host for ongoing discussions on medical device development.
Love this episode? Leave a review on iTunes! Have suggestions or topics you’d like to hear about? Email us at podcast@greenlight.guru.
The Global Medical Device Podcast powered by Greenlight Guru is where today's brightest minds in the medical device industry go to get their most useful and actionable insider knowledge, direct from some of the world's leading medical device experts and companies.
Etienne Nichols is a Medical Device Guru and Mechanical Engineer who loves learning and teaching how systems work together. He has both manufacturing and product development experience, even aiding in the development of combination drug-delivery devices, from startup to Fortune 500 companies and holds a Project...