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2019 - US FDA Medical Device QSR, 21 CFR 820 and Quality Management System
Date2019-10-23
Deadline2019-10-23
VenueOnline Event, USA - United States 
Keywords21 CFR Part 820; 21 cfr 820 training; Fda qsr training
Topics/Call fo Papers
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.
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.
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Last modified: 2019-07-06 21:14:10