Device Accessories - Understanding and Implementing the Final Guidance Document 2017

Topics

• How the definition applies to "software as a medical device" SaMD
• The definition of an accessory and parent device from the guidance document - they are not in any regulations
• How to determine the classification status of an accessory
• The three prong approach to application of the accessory definition
• The use of the de novo process for an unclassified accessory
• The two methods of change applicable to a classified accessory

Who should Attend

• Regulatory Affairs Specialists
• Product Marketing Specialists
• Design Engineering Managers
• Device Quality Specialists
• Product Documentation Specialists
• Production Managers
• Risk Management Specialists