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Guideline

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.

DESIGN CONTROL GUIDANCE FOR MEDICAL DEVICE MANUFACTURERS
Internet:http://www.fda.gov/cdrh/comp/designgd.pdf
Origin/Publisher:FDA http://www.fda.gov/cdrh/comp/designgd.pdf
Content:Guidance document which relates to FDA 21 CFR 820.30 and Sub-clause 4.4 of ISO 9001
Status:Guidance
Document Type:Guidance