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)
Read more
FDA and Cybersecurity for SaMD
The implications cybersecurity regulations and standards will have on your Medical Device development!
Read more
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
Read more
Top 3 Requirements for Software as Medical Device (SaMD)
A deeper dive into crucial policies for Software for Medical Device (SaMD) Organizations
Read more
Crucial Do’s and Don’ts of SaMD Development
Explore the unique challenges and considerations of SaMD development.
Read more
What Actually Happens in a Pre-Submission Meeting with FDA? Part I
Understanding the power of utilizing a pre-submission for your medical device.
Read more
FDA Releases Guidance On Cybersecurity for Medical Devices
Why Cybersecurity is crucial in the Medical Device & SaMD Industry
Read more
ISO 14971 Risk Management in Under 5 Minutes
Defining medical device risk while taking a sneak peek into ISO 14971:2019.
Read more