5 Ways to Stay Compliant with 21 CFR Part 11

    Learn how to stay compliant with FDA's Part 11 in the age of automation!
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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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    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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    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 Guidelines for your Medical Device Regulatory Strategy

    Learn how your company can form a Regulatory Strategy in 8 easy steps.
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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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    How to Utilize CAPA in 10 Easy Steps

    Step by step instructions on navigating your Corrective Action & Preventive Action (CAPA) for FDA.
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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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    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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