Predetermined Chance Control Plans for Machine Learning-Enabled Medical Devices
FDA Releases Guidance On Predetermined Change Control Plans for Machine Learning-Enabled Medical Devices
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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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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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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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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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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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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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