A Simple Breakdown of ISO and IEC Standards for SaMD
Understanding the difference and benefits between ISO and IEC Standards for Software as a Medical Device
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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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Pro Tips Surrounding Design Controls for Medical Devices
Breaking Down Design Control Requirements for Medical Device Development Teams
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What are CAPAs?
Learn the purpose of Corrective and Preventive Actions (CAPAs) for Medical Device Development.
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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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ISO 13485 vs. CFR Part 820
A comparative study on the key differences between FDA’s QSR and ISO’s QMS.
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