Leo Eisner's guest appearances

Leo Eisner

Global Medical Device Podcast powered by Greenlight Guru

Meghan Alonso

Mike Drues

Peter Sebelius

Gary Saner

Michael Drues

Ronny Bracken

Mark Swanson

Mitch Levinson

Sara Naab

Matt Romey

Therese Graff

Mike Cremeans

Jon Speer

Taylor Brown

OwlTail

IEC 60601 is a challenge for companies that are developing electronic medical devices. It’s wise to have a guide to help you understand and work through the process, and today we have a guest who will give you the guidance you need.Leo Eisner, founder and principal consultant of Eisner Safety Consultants, knows IEC 60601 inside and out. Leo has a great background in compliance, quality systems, and more. For nearly two decades, he has been heavily involved in the standards committees and has been working as a consultant. Eisner Safety Consultants helps clients get through the product safety and regulatory processes. Today he shares some great insights on the 60601 approval process.Some of the topics we’ll discuss today include:●What makes the 60601 process different from the other regulatory compliance processes.●Some of the details on the differences between creating a device for the ER vs. for home use and for use in other types of facilities.●Tips on preparing for success when creating a timeline for getting through the 60601 process, as well as some of the steps involved.●Differences between different types of safety labs and the criteria that’s vital to understand to help you make the right choice.●What to do early in the process of product design and development to be sure you’re on the right track long before you get to the production phase.●Why it’s vital to keep the 60601 standard in mind, not only when it comes to meeting the standards, but also when it comes to patient safety.

IEC 60601 is a challenge for companies that are developing electronic medical devices. It’s wise to have a guide to help you understand and work through the process, and today we have a guest who will give you the guidance you need. Leo Eisner, founder and principal consultant of Eisner Safety Consultants, knows IEC 60601 inside and out. Leo has a great background in compliance, quality systems, and more. For nearly two decades, he has been heavily involved in the standards committees and has been working as a consultant. Eisner Safety Consultants helps clients get through the product safety and regulatory processes. Today he shares some great insights on the 60601 approval process. Some of the topics we’ll discuss today include: ●What makes the 60601 process different from the other regulatory compliance processes. ●Some of the details on the differences between creating a device for the ER vs. for home use and for use in other types of facilities. ●Tips on preparing for success when creating a timeline for getting through the 60601 process, as well as some of the steps involved. ●Differences between different types of safety labs and the criteria that’s vital to understand to help you make the right choice. ●What to do early in the process of product design and development to be sure you’re on the right track long before you get to the production phase. ●Why it’s vital to keep the 60601 standard in mind, not only when it comes to meeting the standards, but also when it comes to patient safety.

Tips for Success When It Comes to IEC 60601 with Leo Eisner

Standards are absolutely critical when you are developing a medical device.You need to understand why these standards are important when developing your product for your regulatory submission. You need to know what they are and understanding how to incorporate them as part of your design and development process at the beginning rather at the end.Today's guest Leo Eisner from Eisner Safety Consultants is a leading expert in medical device safety standards. He even has built a database to help you navigate the process. I encourage you to take a look.“The standards are rigorous and it’s for good reason.” - Leo EisnerLeo has over thirty years of experience in product safety and is a leading speaker and author when it comes to medical device safety. He knows quality systems, knows how to audit and test. He has recently released the “Standards Reconnaissance Database” so that medical companies can leverage his expertise.“Your indications for intended use [of your device] are directly impacted by the markets where you plan for your product to be used.”  -Jon SpeerToday Leo &amp; Jon discuss:-How Leo’s career in standards began-Why standards are important-Why should I care about standards regarding my medical device-Standard IEC-60601-Standards Reconnaissance Database-Benefits of standards-Updates to standards-Classifying your product, drafting a test plan, checking against standards"The most important reason you should care about standards is because of your regulatory submissions and your design process." - Leo EisnerLeo’s best recommendation when it comes to standards is to know your product well enough to know what standards apply early in the development process - from there you’ll know how much preparation and testing it will take.To get in touch with Leo please be sure to check out his website at Eisner Safety Consultants or feel free to shoot him an email at Leo at EisnerSafety dot com.

Standards are absolutely critical when you are developing a medical device. You need to understand why these standards are important when developing your product for your regulatory submission. You need to know what they are and understanding how to incorporate them as part of your design and development process at the beginning rather at the end. Today's guest Leo Eisner from Eisner Safety Consultants is a leading expert in medical device safety standards. He even has built a database to help you navigate the process. I encourage you to take a look. “The standards are rigorous and it’s for good reason.” - Leo Eisner Leo has over thirty years of experience in product safety and is a leading speaker and author when it comes to medical device safety. He knows quality systems, knows how to audit and test. He has recently released the “Standards Reconnaissance Database” so that medical companies can leverage his expertise. “Your indications for intended use [of your device] are directly impacted by the markets where you plan for your product to be used.” -Jon Speer Today Leo &amp; Jon discuss: -How Leo’s career in standards began -Why standards are important -Why should I care about standards regarding my medical device -Standard IEC-60601 -Standards Reconnaissance Database -Benefits of standards -Updates to standards -Classifying your product, drafting a test plan, checking against standards "The most important reason you should care about standards is because of your regulatory submissions and your design process." - Leo Eisner Leo’s best recommendation when it comes to standards is to know your product well enough to know what standards apply early in the development process - from there you’ll know how much preparation and testing it will take. To get in touch with Leo please be sure to check out his website at Eisner Safety Consultants or feel free to shoot him an email at Leo at EisnerSafety dot com.

Why Using the Proper Standards for Your Regulatory Submission is So Important with Leo Eisner