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Quality management system fda. Quality system regulation overview. Fda and parenteral drug association pda joint regulatory conference september 8 10 2014 washington d c. Other device specific guidance documents prepared by cdrh for the medical device industry. Cgmp requirements for devices in part 820 21 cfr.
The fda has concluded that modern quality systems when coupled with manufacturing process and product knowledge and the use of effective risk management practices can handle many. Fda ema requirements. Fda small business. Fda gmp iso 13485 oriel stat a matrix offers medical device manufacturers a structured method for implementing a quality system that is compliant with fda s quality system regulation 21 cfr 820 and or iso 13485.
Branch chief postmarket and consumer branch. The quality systems for fda regulated products food drugs biologics and devices are known as current good manufacturing practices cgmp s. The fda worldwide quality system requirements guidebook for medical devices. Regulatory education for industry redi burlingame ca.
June 17 2014.
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