A Simple Guide to 510(k) Applications for Medical Devices
Easy Guidance for Abbreviated, Special, and Traditional 510(k) Clearance Applications
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Know the basics about Meeting with the FDA for Medical Device Pre-Submissions.
Ready to bring your medical device to market? Find out how to navigate the pre-submission process with this essential guide.
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6 Preliminary Questions Around FDA’s RTA Policy for 510(k)
Outlining the Preliminary Qualifications and Evaluation of FDA’s Updated RTA Policy for 510(k) Submissions
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8 Regulatory Strategy Guidelines for Your Medical Device
Learn how your company can form a Regulatory Strategy in 8 easy steps.
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What Actually Happens in a Pre-Submission Meeting with FDA? Part II
How to get the most out of Pre-Submission meetings with the FDA.
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How to Create Successful SOPs for your Medical Device
Explore the key considerations for Standard Operating Procedures (SOPs) for Medical Device Companies
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What are Standard Operating Procedures (SOPs)?
Defining SOP’s as they pertain to your Medical Device.
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Quick Guide to a Successful Clinical Development Program
Unpacking the 4 stages of a Clinical Development Program.
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FDA’s Emergency Use Authorization (EUA) to Combat the Coronavirus
How Emergency Use Authorization is shaping the regulatory landscape of Healthcare during the COVID-19 pandemic.
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A Quick & Easy Guide to FDA Pre-Submissions
A simple guide to conquering your Pre-Submission Meeting with FDA, plus some free tools!
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