Quality System Regulations (QSR) for the Medical Device Industry

This two-day course is designed to give you the most updated information on the FDA requirements for the QSR and product safety. Case studies, workshops and interactive discussions are used throughout the sessions to demonstrate how these new regulations affect you and your business.

• Understand the FDA’s regulatory history affecting medical devices manufactured for use in the United States
  
  
• Learn about the FDA’s objective to harmonize US medical device regulations with the international community
  
  
• Review standards such as risk analysis and guidance documents
  
  
• Learn inspectional strategies used by the FDA

• Explanation of the Quality System Regulation (QSR)
  
• How TC 210 affects change within the medical device industry
  
• Harmonization with international regulations
  
• How to make the transition into a tiered quality system
  
• Relationship between ISO 9000/ISO 13485 and the European Union’s CE Marking requirements
  
• How the guidance documents relate to the requirements
  
• Timelines for compliance
  
• Overview of Design Control
  
• FDA’s expectations of Product Safety