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Important Links

Useful Links to Additional Information. fda-consultant.com United States Food and Drug Administration. (FDA) FDA's Center for Devices and Radiological Health National Institutes of Health, USA. (NIH) American National Standards Institute (ANSI) International Electrotechnical Commission (IEC) ISO - International Organisation for Standardisation Sterilization Validation Services: Pharmaceutical Sys...

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Checklist

CHECKLIST FOR WRITTEN DOCUMENTATION REQUIRED BY THE 21 CFR 803 (MDR) and 21 CFR 820(QSR, cGMP) Courtesy of fda-consultant.com Required Procedures 21 CFR Section Check Procedures for MDRs 803.17 A documented quality program 820.20 Documentation of Management review of quality system at defined intervals and at sufficient frequency 820.20 Procedures for audits 820.22 Records of audits 820.22 Procedu...

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fda-consultant.com

"); Assisting the Medical Device Community with FDA regulatory services,working worldwide. Now celebrating 22 years of service! Main TEL:+1-239-244-1735 Washington, D.C.:+1-301-541-8037 FAX:+1-206-260-4162 Skype:fda_consult Email: fda.help.now@gmail.com Services Offered: FDA Submissions: 510(K), IDE, PMA, Product Reports. (Over 200 510(k)s cleared) Our 510(k) list Medical Device License Submis...

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Useful Documents

Useful Documents from fda-consultant.com Revision of GMP, now called the Quality System Regulation. Look for text in RED where written procedures and documents are required. Look for text in GREEN where designated persons or individuals are required. Translations of the Quality System Regulation (Medical Device GMP) for our International Clients Quality System Regulation (GMP) in Italian (PDF form...

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