{"id":4652,"date":"2016-02-22T22:52:39","date_gmt":"2016-02-22T22:52:39","guid":{"rendered":"http:\/\/www.eisnersafety.com\/eisnersafetycom\/?p=4652"},"modified":"2022-06-12T18:26:03","modified_gmt":"2022-06-12T18:26:03","slug":"why-using-proper-standards-for-your-regulatory-submission-is-so-important-podcast","status":"publish","type":"post","link":"https:\/\/eisnersafety.com\/eisnersafetycom\/2016\/02\/22\/why-using-proper-standards-for-your-regulatory-submission-is-so-important-podcast\/","title":{"rendered":"Why Using Proper Standards for Your Regulatory Submission is So Important – Podcast"},"content":{"rendered":"

Jon Speer, founder and VP of QA\/RA @ greenlight.guru<\/a> and I, Leo Eisner, Principal Consultant of Eisner Safety Consultants, had a really interesting & dynamic conversation that we are sharing as a podcast with you\u00a0on\u00a0the use of the proper standards for your medical device regulatory submissions and why it is so important<\/a>.
\n\"Episode13_Global<\/a><\/p>\n

We have teamed up with greenlight.guru<\/a>, a specialized electronic Quality Management System (eQMS) platform specifically designed for small to\u00a0mid-size Medical Device companies. greenlight.guru<\/a> will\u00a0reduce 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<\/a> and Eisner Safety Consultants\u00a0are both well equipped with our\u00a0specialized expertise and know how to get your device to market, and more importantly \u2013 STAY in market!<\/p>\n

Standards are absolutely critical when you are developing a medical device.<\/p>\n

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.<\/p>\n

Listen Now:<\/em><\/h4>\n

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\u201cYour indications for intended use [of your device] are directly impacted by the markets where you plan for your product to be used.\u201d –<\/em>Jon Speer<\/p>\n

In the Podcast<\/a> Leo & Jon discuss:<\/em><\/p>\n