Medical Device Single Audit Program (MDSAP) Explained
A simple breakdown of MDSAP, how it can benefit your company, and detailed instructions on how to get started.
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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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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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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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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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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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