My Software Is a Medical Device (SaMD). Now What?

My Software Is a Medical Device … if that’s you, check out this upcoming webinar.  Our very own John Murray will participate in a webinar on August 25, 2020, and join a roundtable discussion with Bakul Patel, Director, Division of Digital Health at FDA.  Shawnnah Monterrey, CEO @BeanStock Ventures will moderate the discussion.

You can register for the webinar at this link:  https://us02web.zoom.us/webinar/register/8815964798219/WN_w4Ri7AysQUmyfIOZx2-21Q.

[View the recording of the webinar here: YouTube: “Webinar: My Software is a Medical Device (SaMD). Now What?”]

Software as a Medical Device (SaMD) products have grown exponentially over the last several years and assuring software quality can be challenging for many that are new or inexperienced in safety critical industries.  Fundamental methodologies such as safety risk management, multiple levels of software verification, and structured and repeatable software development processes may be unfamiliar to SaMD manufacturers.  However, many SaMD companies are bringing new and highly efficient methodologies and “software factory” tools to the table.  The question is how to bring these two sides together.  John and others at SoftwareCPR can help.  We can bridge the gap and help SaMD companies be both agile/lean and compliant – but most importantly, assure safe medical device software.

See more of our posts related to SaMD:  https://www.softwarecpr.com/tag/samd/

Let us know if we can help!

About the author

Brian is a biomedical software engineer - whatever that is! Started writing machine code for the Intel 8080 in 1983. Still enjoys designing and developing code. But probably enjoys his garden more now and watching plants grow ... and grandkids grow!

SoftwareCPR Training Courses:

IEC 62304 and other Emerging Standards Impacting Medical Device Software

Being Agile & Yet Compliant

ISO 14971 SaMD Risk Management

Software Risk Management

Medical Device Cybersecurity

Software Verification

IEC 62366 Usability Process and Documentation

Or just email training@softwarecpr.com for more info.

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