FDA Computer Software Assurance Guidance

This is an FDA guidance document titled "Computer Software Assurance for Production and Quality Management System Software," issued February 3, 2026. It provides recommendations for how medical device manufacturers should establish confidence that the computer software they use in production and quality management systems is fit for its intended purpose.

Type

GMP + GDP

Organisaties:

US FDA

Onderwerpen:

Software Medical Devices

Versietijdlijn

Chronologische releasegeschiedenis

FDA Computer Software Assurance Guidance

Versiemijlpaal

Publicatiedatum

2026-02-03

Ingangsdatum

Niet opgegeven

Belangrijkste updates: It provides recommendations for how medical device manufacturers should establish confidence that the computer software they use in production and quality management systems is fit for its intended purpose.

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Bronnen

Training

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FDA Computer Software Assurance Guidance