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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Advantages of a Quality Management System with Jira Integration
Risk management guide for Medical Device Companies on Atlassian’s Jira!
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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 does FDA’s Draft Predetermined Change Control Plan PCCP for AIML-DSF recommend?
Marketing Submission Recommendations for a Predetermined Change Control Plan (PCCP) for Artificial Intelligence/Machine Learning (AI/ML)-Enabled Device Software Functions
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Top 3 Requirements for Software as Medical Device (SaMD)
A deeper dive into crucial policies for Software for Medical Device (SaMD) Organizations
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Crucial Do’s and Don’ts of SaMD Development
Explore the unique challenges and considerations of SaMD development.
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FDA's Quality Management System Regulation Revised (QMSR) for Medical Devices
Simple Guide to FDA’s harmonization of 21 CFR part 820 with ISO 13485:2016
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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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What Actually Happens in a Pre-Submission Meeting with FDA? Part II
How to get the most out of Pre-Submission meetings with the FDA.
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