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Regulatory Outlook |
Published: April 22, 2009
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Good Laboratory Practice for Nonclinical Laboratory Studies, 21 CFR 58
www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=58
www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=58
Medical Device Quality System Manual: A Small Entity Compliance Guide
www.fda.gov/cdrh/dsma/gmpman.html
www.fda.gov/cdrh/dsma/gmpman.html
Medical Device Reporting
www.fda.gov/cdrh/mdr
www.fda.gov/cdrh/mdr
Medical Device Recalls, Corrections, and Removals
www.fda.gov/cdrh/devadvice/51.html
www.fda.gov/cdrh/devadvice/51.html
Guide to Inspections of Quality Systems
www.fda.gov/ora/inspect%5Fref/igs/qsit/qsitguide.htm
www.fda.gov/ora/inspect%5Fref/igs/qsit/qsitguide.htm
AdvaMed Points to Consider When Preparing for an FDA Inspection under the QSIT Corrective and Preventive Action Subsystem
www.advamed.org/NR/rdonlyres/E54C4BA9-A454-4FFE-8480-A7807529C9CC/0/pointstoconsider6501.pdf
www.advamed.org/NR/rdonlyres/E54C4BA9-A454-4FFE-8480-A7807529C9CC/0/pointstoconsider6501.pdf
Investigational Device Exemptions, 21 CFR 812
www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRsearch.cfm?CFRPart=812
www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRsearch.cfm?CFRPart=812
Guidance for Industry: Product Recalls, Including Removals and Corrections
www.fda.gov/ora/compliance_ref/recalls/ggp_recall.htm
www.fda.gov/ora/compliance_ref/recalls/ggp_recall.htm
ISO 13485:2003: Medical Devices —Quality Management Systems—Requirements for Regulatory Purposes
www.iso.org
www.iso.org
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