US FDA Medical Device QSR, 21 CFR 820 and Quality Management System
Website https://www.complianceonline.com/us-fda-medical-device-qsr-21-cfr-820-and-quality-management-system- |
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Deadline: October 23, 2019 | Date: October 23, 2019
Venue/Country: U.S.A
Updated: 2019-07-04 21:36:13 (GMT+9)
Call For Papers - CFP
What are US FDA expectations for a compliant device QSR?How can a company develop and maintain a dual QMS.Basic Systems / SOPs.QSIT (FDA’s Quality System Inspection Technique)Brief discussion of ISO 14971 (Device Risk Management) and IEC 62366-1 (Use Engineering / Human Factors) and where they fit.Current areas of FDA concern.Other US FDA device requirements.Maintaining compliance under increasing regulatory expectations.Similarities /differences to ISO 13485 and the MDR.Keywords: Accepted papers list. Acceptance Rate. EI Compendex. Engineering Index. ISTP index. ISI index. Impact Factor.
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