FDA Guidance for Industry, FDA Reviewers and Compliance on Off-The-Shelf Software Use in Medical Devices

Titel:
FDA Guidance for Industry, FDA Reviewers and Compliance on Off-The-Shelf Software Use in Medical Devices
Herkunft/Verlag:

FDA, http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm073779.pdf

Dokumentenart:
Guidance
Inhalt:
Anforderungen an die Zulassungsdokumentation bei Medizinprodukten die OTS (Off-The-Shelf) Software beinhaltet

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