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July 25, 2021
Most medical device manufacturers use many, many software programs, systems, or services to automate quality system This software is not to be confused with product software - that is, software that runs as part of a medical device.  Medical device in this context could be custom hardware devices or Software as a Medical Device (SaMD)....
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One of the most important references in creating a software development lifecycle process to assure software quality is the FDA guidance document, “General Principles of Software Validation.”  This guidance document has been around for many years.  The current version, 2.0, was released in 2002.  To many in the industry, this guidance is simply referred to...
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Cybersecurity Review

Our cybersecurity experts are NESSUS Pro Licensed and can quickly remediate cybersecurity deficiencies with your medical device or digital health software.  Planning, requirements, validation, and submissions – we can assist with all.

Interested in having a conversation?  Email us to arrange a Zoom meeting or call us at +1 781-721-2921.

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