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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The Ultimate SaMD Development Plan
Easy Ways to Meet FDA Regulatory Requirements with Your Software Development Plan
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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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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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The Ultimate Quality Management System for Life Sciences
Must-Have Features & Functionality for Your Quality Management System (QMS)
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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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What is ISO 13485:2016?
An easily digestible overview of ISO 13485 and how it applies to your medical device company.
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ISO 13485 - Regulatory Requirements on Medical Devices
How embracing regulations can give you a leg up on your competition.
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Medical Device Software & SaMDs: A Crash Course
A quick and easy rundown of ISO and IEC standards.
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