Medical Devices; Current Good Manufacturing Practice (CGMP) Final Rule; Quality System Regulation

U.S. Food and Drug Administration. (1996). Medical Devices; Current Good Manufacturing Practice (CGMP) Final Rule; Quality System Regulation. Federal Register.

Type

Book chapter

Intellectual base

Review or monograph

Year

1996

Link

https://www.fda.gov/medical-devices/postmarket-requirements-devices/quality-management-system-regulation-qmsr

Cited by

1 citation across 1 artifact.

Each citation links to the sentence it supports in the citing article.

Mechanisms

• Corrective Action Review
  • In regulated safety and quality settings this is formalized as the effectiveness check in a corrective-and-preventive-action process

    This sourceRequires corrective and preventive actions to be verified or validated for effectiveness.

Verification

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Registry ID ref:5398620e01dc · see in the full table