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The Ultimate SaMD Development Plan

Easy Ways to Meet FDA Regulatory Requirements with Your Software Development Plan
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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 are CAPAs?

Learn the purpose of Corrective and Preventive Actions (CAPAs) for Medical Device Development.
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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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Using Agile in SaMD Development Under IEC 62304

Uncovering how Agile practices fulfill Software as a Medical Device (SaMD) Development
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What is FDA's 21 CFR Part 820?

Unpacking the FDA guidelines and regulations under 21 CFR Part 820.
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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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Quick Guide to a Successful Clinical Development Program

Unpacking the 4 stages of a Clinical Development Program.
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