Free Documents and Websites

Survey Results
Articles
Complaint Handling
CARS

FDA
Compliance Program Guidance Manual
Device Advice
FDA Warning Letters

COMPLIANCE
Wishing for a Compliant CAPA System
Points To Consider for the QSIT Design Controls Subsystem
Points to Consider for the QSIT Corrective and Preventive Actions (CAPA) Subsystem
Points to Consider for the QSIT Management Controls Subsystem
Code of Ethics for Interactions with Health Care Professionals
Global Harmonization Task Force

INSPECTION
Medical Device Inspections: Required Reading
Guide to Inspection of Quality Systems
Inspections Operations Manual
Laws Enforced By the Food and Drug Administration
ORA Field Management Directive
Establishment Inspection Report for Rockwell Medical Technologies

QUALITY
Correspondence Between ISO 13485 and the Quality System Regulation
Comparison Matrix: ISO 14971:2000 and ISO 14971:2007
Implementation of Risk Management Principles Within a Quality System
Quality System Regulation

ASSISTANCE
Root Cause Investigation for CAPA
Medical Devices Today
FOI Services
Records Management
Medical Device Link
Optimizing FDA Compliance