FMDIC Risk Management, CAPA, and Training: An Educational Forum

In order to best utilize the FMDIC Risk , CAPA, and Training Educational Forum, we recommend your read the following online references. Portable Document Format (pdf) files require Adobe Acrobat Reader to display and print. Word document (doc) files require Microsoft Word.

	Medical Device Quality Systems Manual: A Small Entity Compliance Guide http://www.fda.gov/cdrh/dsma/gmpman.html
	FDA CDRH Device Advice: Good Manufacturing Practices (GMP) / Quality System (QS) Regulation http://www.fda.gov/cdrh/devadvice/32.html
	Medical Device Use-Safety: Incorporating Human Factors Engineering into Risk Management http://www.fda.gov/cdrh/humfac/1497.html

	Wireless Medical Telemetry Risks and Recommendations http://www.fda.gov/cdrh/comp/guidance/1173.html
	Criteria for Significant Risk Investigations of Magnetic Resonance Diagnostic Devices - Guidance for Industry and FDA Staff http://www.fda.gov/cdrh/ode/guidance/793.html

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