A Regulatory Approach Manual for Device Software Functions
Understanding the policies for your Medical Device Software Functions
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5 Myths of Automation in Healthcare, Debunked!
Automation Myths standing in the way of progress in our healthcare system.
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6 Regulatory Pathways to Bring Your Medical Device to Market
Uncover which regulatory pathway is right for your medical device!
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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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5 Crucial Ways Digital Health is Mitigating COVID-19
A deep dive into Digital Health's role in curbing this global coronavirus 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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Top 20 Medical Device Conferences to Attend in 2020
A simple breakdown of 20 conferences you don't want to miss this year.
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20 New FDA Biological Approvals in 2019
A comprehensive table of CBER's 20 new biological approvals and their corresponding approval dates, intended uses, and companies.
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48 New Drug FDA Approvals in 2019
A comprehensive table of the 48 new drug approvals and their corresponding active ingredients, diseases, estimated sales, and companies.
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The Secret to GxP Cloud Compliance in 4 Minutes or Less
Learn how to achieve GxP Cloud Compliance and simplify your Cloud Validation process with 1 simple trick.
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