Crucial Do’s and Don’ts of SaMD Development
Explore the unique challenges and considerations of 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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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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A Regulatory Approach Manual for Device Software Functions
Understanding the policies for your Medical Device Software Functions
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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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6 Regulatory Pathways to Bring Your Medical Device to Market
Uncover which regulatory pathway is right for your medical device!
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5 Steps to Obtain a CE Marking on Your Medical Device
How to utilize ISO 13485 to acquire a CE Marking on your Medical Device.
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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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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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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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