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 discussed 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.
Quotes from Leo:
“Give yourself a buffer. There will be bumps in the road... guaranteed.”
“Some labs know medical very well, and there are a lot that don’t.”
“Start early.... Testing can take six to 12 weeks.”
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.