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21 CFR Part 820 QSR with Updated 2026 QMSR
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21 CFR Part 820 QMSR with ISO 13485 Checklist & Part 11
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21 CFR Part 820 2026 QMSR
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21 CFR Parts 11, 820 QSR and 2026 QMSR
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GMP Medical Device Master Reference
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21 CFR 3, 4, 11, 210/211, 820, ICH Q7 - Combination Product GMP Master
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US FDA, Canadian and European MDR
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21 CFR Part 4 Combination Products with 820
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21 CFR 806 - Medical Devices; Reports of Corrections and Removal
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US, EU and Canadian Medical Device Combination
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21 CFR 820 - Quality Management System Regulations-ENGLISH/SPANISH
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21 CFR 820 - QMSR-Spanish
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21 CFR 58, 820 - GLP and QMSR
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21 CFR 814 - Premarket Approval of Medical Device
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21 CFR 812 - Investigational Device Exemptions
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21 CFR 810 - Medical Device Recall Authority
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21 CFR 809 - In-Vitro Diagnostic Products
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21 CFR 803 - Medical Device Reporting
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21 CFR 801 - Labeling - Medical Device
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GMP Manufacturing Handbook
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GMP International Master Reference
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21 CFR 11, 210/211, 820 QMSR - Electronic Records with Drug and Device GMPs
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21 CFR Part 822 - Postmarket Surveillance
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21 CFR Part 830 Unique Device Identification
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21 CFR Part 860 Medical Device Classification Procedures.
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QSIT -Quality System Inspection Technique
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21 CFR Part 821 Medical Device Tracking Requirements
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8-Hour Monthly GMP Training, Certificate, GMP Handbook & e-Workbook
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Audit - 1 Day Onsite All Inclusive - U.S.
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Audit - 2 Day Onsite All Inclusive - U.S.
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Audit - 3 Day Onsite All Inclusive - U.S.
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Audit - 1 Day Onsite All Inclusive - International
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Audit - 2 Day Onsite All Inclusive - International
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Audit - 3 Day Onsite All Inclusive - International
Regular price $9,995.00Regular priceSale price $9,995.00 -
Audit and Training - 1 Day Onsite All-Inclusive Audit with 1 Day Training - U.S.
Regular price $7,990.00Regular priceSale price $7,990.00
Collection: Medical Device
NOTE: New Medical Device QMSR last updated February 2026