ISO 13485 - Regulatory Requirements on Medical Devices
How embracing regulations can give you a leg up on your competition.
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FDA Pre-Cert 101: Beginner's Guide + Latest Updates
A simple breakdown of the Software Pre-Certification Program and how it affects your company.
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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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ISO 14971 Risk Management in Under 5 Minutes
Defining medical device risk while taking a sneak peek into ISO 14971:2019.
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A Simple Guide to SaMD
Breaking down the basics of Software as a Medical Device (SaMD): risk categorizations and examples.
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