The following guideline can be ordered through the address listed in the "Source/Publisher"-category. In cases in which you can order through the Internet we have established a hyperlink.

FDA DESIGN CONTROL GUIDANCE FOR MEDICAL DEVICE MANUFACTURERS

Origin/Publisher:

FDA, http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm070642.pdf

Document Type:
Guidance
Content:
Guidance document which relates to FDA 21 CFR 820.30 and Sub-clause 4.4 of ISO 9001

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