RK Pine Consulting

Description: · ISO 13485:2003 – QMS requirements · FDA Quality System Regulations · Canadian Medical Devices Regulation including CMDCAS · Medical Device Directive (MDD) including CE Marking for Class I, II and II devices · Other supporting medical device and quality system requirements and guidelines including MEDDEV, GHTF and ISO standards

Keywords: ISO 13485 2003 QMS requirements FDA Quality System Regulations Canadian Medical Devices Regulation CMDCAS Medical Device Directive MDD) CE Marking Class I, II and III devices medical device quality system requirements guidelines MEDDEV GHTF ISO standards 510K approval PMA notified body consulting advice Premarket Notifications 510k Premarket Approvals PMA Technical Files Design Dossiers Canadian Medical Device License Applications Design Control

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Rkpconsulting.com

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RKPCONSULTING.COM - Site Location
Country/Flag	United States
City/Region/Zip Code	Chicago, Illinois, 60606
Organization	Affinity Internet
Internet Service Provider	Affinity Internet