How to Meet Regulatory Expectations for SaMD

    Leveraging these expectations to ensure the highest level of quality for your Software as a Medical Device (SaMD)
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    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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    Crucial Do’s and Don’ts of SaMD Development

    Explore the unique challenges and considerations of SaMD development.
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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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    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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