Useful Documents from fda-consultant.com

• Revision of GMP, now called the Quality System Regulation. Look for text in RED where written procedures and documents are required. Look for text in GREEN where designated persons or individuals are required.

Translations of the Quality System Regulation (Medical Device GMP) for our International Clients

Quality System Regulation (GMP) in Italian (PDF format)

Quality System Regulation (GMP) in Japanese (PDF format)

Quality System Regulation (GMP) in German (PDF format)

Quality System Regulation (GMP) in Swedish (PDF format)

• Checklist for Documents Required in a Traditional 510(k).
  
• Checklist for Documents Required in an Abbreviated 510(k).
  
• Checklist for Documents Required in a Special 510(k).
  
  
• Checklist for Documentation Required by GMP. (Updated)
  
• Risk Analysis
  
• How to make a Freedom of Information Request.

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