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Course Name:
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REGULATORY AND QUALITY SYSTEMS FOR MEDICAL DEVICES
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Course ID:
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1119336 |
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Provider Name:
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ALVAMED INC
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Approved for:
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Description:
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This training program provides an overview of U.S. and international medical device quality standards compliance. Presented by an experienced medical device quality consultant, the training discusses quality system requirements of ISO 13485:2016, U.S. FDA quality system regulations (21 CFR 820, including current Good Manufacturing Practice regulations). The Medical Device Single Audit Program is also discussed (MDSAP streamlines medical device compliance for companies marketing products in Australia, Canada, Brazil, Japan, and the United States). Particular attention is paid to certification and auditing requirements for compliance. Attendees will learn how to ensure compliance to these important standards and programs for medical devices. |
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Training Subtype:
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Advanced Skills
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Location:
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935 Great Plain Ave
#166
Needham, MA 02492
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Program Results In:
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-NA-
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Course Length:
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6 week(s)
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Average No. of Hours/Week:
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5 Hrs
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On-line Course Schedule:
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Cost/Student:
Includes:
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$5,000.00
Tuition
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Flat Rate Course:
(The cost of this course is based on a flat fee, regardless of the number of employees attending the course)
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Yes
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Performance Summary
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Program Year (Most Recent):
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0
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Number of Program Participants:
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0 |
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Participant Completion :
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0
0% |
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Number of Educational Outcomes:
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0
0% |
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