Reading

In order to best utilize the training courses FMDIC, INC. may offer we recommend your read the following online references. Portable Document Format (pdf) files  require Adobe Acrobat Reader to display and print.

Highly Recommended

• Medical Device Quality Systems Manual: A Small Entity Compliance Guide
• FDA CDRH Device Advice: Good Manufacturing Practices (GMP) / Quality System (QS) Regulation
• Guideline on General Principles of Process Validation
• General Principles of Software Validation; Final Guidance for Industry and FDA Staff
• Medical Device Use-Safety: Incorporating Human Factors Engineering into Risk Management
  http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm094460.htm    
• 21 CFR 820 – Quality System
• The Good Manufacturing Practice (GMP – Quality System Regulation) Final Rule (Federal Register) and Preamble
• Quality System Inspection Technique (QSIT) Handbook 
• Compliance Program 7382.845 – Inspections of Medical Device Manufacturers

Recommended

• Process Validation Guidance for Medical Device Manufacturers, Global Harmonization Task Force
• ISO 9001 Comparison to the Quality System
• Do It By Design: An Introduction to Human Factors in Medical Devices