[Irregularly Scheduled] FDA Regulations & QSR / QMSR Study Session

This seminar will provide a clear explanation of the overall picture of U.S. medical device regulations, QSR/QMSR requirements, and FDA inspection strategies for manufacturers exporting medical devices and in vitro diagnostic products to the United States.
<Content>
● Overview of U.S. medical device regulations
● Product classification
● Manufacturer registration (facility registration) and product registration
● 2024 revised Quality Management System Regulation (QMSR)
● Quality System Regulation (QSR)
● Quality System Inspection Technique (QSIT)
● Medical Device Reporting System (MDR)
● FDA inspections
● Responses to FDA inspection findings
● 21 CFR 820, English-Japanese comparison of QSR/QMSR requirements

Date and time | Tuesday, Apr 23, 2024 ~ Thursday, Nov 07, 2024 10:00 AM ~ 04:00 PM 4/23, 6/26, 7/25, 8/27, 11/7 |
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Entry fee | Charge 49,000 yen (including text, certificate, and tax) |
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