FDA Process Analytic Technology Presentation

The FDA slides at the link provided describe the history and intent of PAT. This approach involves in-process continuous monitoring of manufacturing processes and validation of these systems to allow dynamic feedback rather than static settings.:

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.

office@softwarecpr.com

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