Using Agile in SaMD Development Under IEC 62304

Uncovering how Agile practices fulfill Software as a Medical Device 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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The Ultimate SaMD Development Plan

Easy ways to meet FDA Regulatory Requirements with your Software Development Plan
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4 Ways AAMI TIR45 Proves Beneficial for SaMD Development

Easy Guidance for SaMD Development and Agile Practices
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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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5 Best Practices for Pharmaceutical Labeling

How strategic labeling can improve regulatory compliance and operational efficiency
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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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A Regulatory Approach Manual for Device Software Functions

How to effortlessly define a Regulatory Approach for your Medical Device Software Function
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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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