What Standards Apply to My Device?

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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Key timestamps

• [03:20] – Introduction to Leo Eisner and his background in medical device standards
• [10:15] – Why standards like IEC 60601 are crucial for medical device development
• [18:45] – Steps for identifying the right standards for your product
• [27:00] – Common mistakes and the consequences of ignoring standards
• [38:50] – How to integrate standards into your design process
• [47:35] – How startups can navigate standards with limited resources
• [58:00] – Tools for staying updated on changing standards and regulations
• [1:09:40] – Final advice from Leo on ensuring regulatory success

Top takeaways from this episode

1. Regulatory Compliance as a Design Input – Standards such as IEC 60601 are not just hurdles but key design inputs.
2. Global Market Variations – Different countries have unique regulatory demands; understanding these early can avoid costly delays.
3. Atomic Standards – Future standards are becoming more "atomic," meaning they’ll be broken down into more easily applicable, smaller parts.

Practical tips for MedTech professionals

1. Start Early with Standards – Review applicable standards in the initial design phase to avoid costly delays later.
2. Use the Right Tools – Tools like MedBoard and the FDA’s guidance database can help you stay updated.
3. Seek Expert Help – If you're a startup or lack in-house resources, work with a qualified consultant to navigate the regulatory landscape efficiently.

MedTech 101

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.

Related links

• 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.

Memorable quotes from this episode

• "When you really think about it, all this work leads to safer medical devices on the market—that’s crucial." – Leo Eisner
• "Standards may seem like obstacles, but they’re design inputs that ensure your device will work as intended in every scenario." – Etienne Nichols
• "If you don’t integrate standards early in the design phase, you bring design risk later into the project, which can be very costly." – Leo Eisner

Audience feedback

Love this episode? Leave a review on iTunes! Have suggestions or topics you’d like to hear about? Email us at podcast@greenlight.guru.

Sponsors

• Greenlight Guru: Streamline your medical device processes with Greenlight Guru’s quality management and electronic data software. Visit Greenlight Guru to learn more.
• Rook Quality Systems: Achieve FDA and ISO compliance effortlessly with Rook Quality Systems. Visit rookqs.com for more information.

About the Global Medical Device Podcast:

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.

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