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
Internet:
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