Multi-Combo 2 - GMPs for Medical Device

Mult-Combo 2 Includes the GMPs for Medical Device Industry

Custom Order - 10 Book Minimum!

Over 800 Pages of Regulations and Guidance

• 21 CFR 11 - Electronic Records with Scope and Application
• 21 CFR 210/211 Drug GMPs
• 21 CFR 210/211 Keyword Index
• 21 CFR 801 - Labeling - Medical Device
• 21 CFR 803 - Medical Device Reporting
• 21 CFR 806 - Medical Devices; Reports of Corrections and Removal
• 21 CFR 807 - Estab. Reg. and Device Listing for Manuf. and Initial Importers of Devices
• 21 CFR 809 - In-Vitro Diagnostic Products
• 21 CFR 810 - Medical Device Recall Authority
• 21 CFR 812 - Investigational Device Exemptions
• 21 CFR 814 - Premarket Approval of Medical Device
• 21 CFR 820 - with Quality System Regulations (QSR) Audit Checklist
• 21 CFR 821 - Medical Device Tracking Requirements
• 21 CFR 822 - Postmarket Surveillance
• EU GMPs - Chapter 1 - 9
• Annex 11 Computerized Systems
• Annex 15 Qualification and Validation
• ICH Q8(R2) - Pharmaceutical Development
• ICH Q9 - Quality Risk Management
• ICH Q10 - Pharmaceutical Quality System
• General Principles of Software Validation
• 21 CFR 820 - with Medical Device QSIT Manual
• Inspection of Medical Device Manufacturers Document issued on: June 15, 2006 Program 7382.845
• 93/42/EEC Medical Device Directive with 2007 Updates
• Medical Device Quality Systems Manuel
• PMA Premarket Approval and 510 (k) Guidance