FDA Technical Reference on Software Development

FDA Office of Regulatory Affair’s “TECHNICAL REFERENCE ON SOFTWARE DEVELOPMENT” issued July 1, 1987 as guidance to inspectors regarding software. This guidance is dated but still sometimes referenced in other publications. It provides some textbook type information as educational material for use in inspections but is no longer heavily utilized.

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.

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