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Medical Device Industry Handbooks
Medical Device Combination - Standard
1-933734-58-2

Good Clinical Practices (GCP) Regulations for Medical Devices

21 CFR and ICH Parts:

  • 11 - Electronic Records; Electronic Signatures
  • 50 - Protection of Human Subjects
  • 54 - Financial Disclosure by Clinical Investigators
  • 56 - Institutional Review Boards
  • 807 - Establishment Registration and Device Listing for Manufacturers and Initial Importers of Devices
  • 812 - Investigational Device Exemptions
  • 814 - Premarket Approval of Medical Devices
  • 820 - Quality Systems Regulations
  • The 510k & Premarket Approval (PMA) Guidance Document

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Part 50 - Protection of Human Subjects
1-933734-11-6
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Part 54 - Financial Disclosure by Clinical Investigators
1-933734-12-4
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Part 56 - Institutional Review Boards
1-933734-13-2
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Part 801 - Labeling - Medical Device
1-933734-42-6
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Part 803 - Medical Device Reporting
1-933734-43-4
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Part 806 - Medical Devices; Reports of Corrections and Removal
1-933734-44-2
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Part 807 - Establishment Registration and Device Listing for Manufacturers and Initial Importers of Devices
1-933734-45-0
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Part 809 - In-Vitro Diagnostic Products
1-933734-46-9
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Part 810 - Medical Device Recall Authority
1-933734-47-7
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Part 812 - Investigational Device Exemptions
1-933734-48-5
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Part 814 - Premarket Approval of Medical Device
1-933734-49-3
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Part 820 - Quality System Regulations
1-933734-50-7
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Part 11 and 820
1-933734-06-X
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Part 11, 210/211 & 820
1-933734-52-3
Parts 11, 210/211 & 820 - The GMP Predicate Rules
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PMA and 510k Guidelines
978-1-935131-94-6
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5 Book Minimum

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Medical Device QSIT Manual with Parts 11, 803, 806, 820 & 821
978-1-935131-10-6
Medical Device QSIT Manual includes 21 CFR Parts 11, 803, 806, 820, 821, & QSIT Manual.
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Part 820 US and Chinese Combination
1-933734-78-7
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Basic Medical Device QSIT with 820
978-1-935131-17-5
Medical Device QSIT Manual includes 21 CFR Part 820 QSR
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US EU Canadian Medical Device Combination
978-1-935131-28-1
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