Jon Speer, founder and VP of QA/RA @ greenlight.guru and I, Leo Eisner, Principal Consultant of Eisner Safety Consultants, had a dynamic & interesting conversation that we are sharing as a podcast with you on tips for success when it comes to IEC 60601-1.
Eisner Safety Consultants has teamed up with greenlight.guru, a specialized electronic Quality Management System (eQMS) platform specifically designed for small to mid-size Medical Device companies. greenlight.guru will reduce your quality management system overhead, a web based system, which is easy and practical to use, will minimize your paper trail, and consequently your need for excessive consultant hours allowing you to focus on your product and getting to market. greenlight.guru and Eisner Safety Consultants are both well equipped with our specialized expertise and know how to get your device to market, and more importantly – STAY in market!
IEC 60601-1 is the gold standard for electrical medical devices around the world. IEC 60601 is a challenge for many companies that are developing electronic medical devices. It’s wise to have a guide to help you understand and work through the process, and in this podcast I discuss with Jon Speer some guidance you can use.
You need to understand why this standard series is important when developing your electrical medical products for your regulatory submissions. You need to know what they are (join our webinar on the 15 Steps to Get IEC 60601-1 Approval on Dec 13, 2016 to get more details) and understanding how to incorporate them as part of your design and development process at the beginning rather at the end of the process.
In the Podcast Leo & Jon discuss:
● 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.
● The Annual Standards Trend Reports (click to get a sample report now & our new pricing) and how you can benefit your company and save money and time.
“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.” – Leo Eisner
A recommendation I tell my clients: When it comes to developing products to the IEC 60601 series of standards is that you need to know your product well enough to determine what standards apply early in the development process – from there you’ll know how much preparation and testing it will take. If this is something you don’t have the expertise or the bandwidth for we can do it for you. One tool I recommend for my clients is we can provide you with our Annual Standards Trend Reports (click for a sample report & our new pricing) so you are strategically positioned for the changes that are coming, the new standards in development and for the recently released standards you didn’t even know exist. View a sample of our Annual Standards Trend Reports & our new pricing. The Annual Standards Trend Reports can to help you navigate the standards that apply to you and save you a lot of money and time.
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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