ASSOCIATION OF MEDICAL DIAGNOSTICS MANUFACTURERS
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RA/QA Topics

RA/QA professionals within the IVD industry face unique situations while assuring quality and compliance standards are met.   AMDM welcomes your suggestions for information to post on this page.  Send suggestions to [email protected]

 
CDRH Learn 
https://www.fda.gov/training-and-continuing-education/cdrh-learn

FDA eSubmitter video tutorial
http://www.fda.gov/ForIndustry/FDAeSubmitter/ucm193862.htm

FDA eSubmitter general info
http://www.fda.gov/ForIndustry/FDAeSubmitter/default.htm 
 

FDA eMDR
http://www.fda.gov/ForIndustry/FDAeSubmitter/ucm107903.htm
 
CDRH Contact Info
https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/contact-us-division-industry-and-consumer-education-dice

OIVD Guidance Documents
https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/guidance-documents-medical-devices-and-radiation-emitting-products

IVD Regulation Overview
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/IVDRegulatoryAssistance/ucm123682.htm

IVD Product Database
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfivd/index.cfm
 
 
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  • About
    • Board
    • Scholarships
    • Contact
  • Members
    • Join
    • Jobs
    • Networking
  • Meetings
    • Meetings
    • Webinar Registration
    • Roundtables
    • Past Presentations
    • RA/QA Topics
    • Resources
  • Store