We have 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!

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.

Listen Now:

[soundcloud url=”https://api.soundcloud.com/tracks/246432259″ params=”color=00cc11&auto_play=false&hide_related=false&show_comments=true&show_user=true&show_reposts=false” width=”100%” height=”166″ iframe=”true” /]

“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

In the Podcast Leo & 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

A vital recommendation I tell my clients: When it comes to standards 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 in several ways.  We can provide you with a tailored list of standards based on your product line(s), or you can sign up for our specially designed Standards Reconnaissance Database to help you navigate the standards that apply to you.

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.

Like this episode? Subscribe today on iTunes, Sticher or SoundCloud.