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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What Actually Happens in a Pre-Submission Meeting with FDA? Part I
Understanding the power of utilizing a pre-submission for your medical device.
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FDA and Cybersecurity for SaMD
The implications cybersecurity regulations and standards will have on your Medical Device development!
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FDA Releases Guidance On Cybersecurity for Medical Devices
Why Cybersecurity is crucial in the Medical Device & SaMD Industry
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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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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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