Device Accessories - Understanding and Implementing the Final Guidance Document 2017 is a webinar that covers topics such as:
- 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
Device Accessories - Understanding and Implementing the Final Guidance Document 2017 is intended for:
- Regulatory Affairs Specialists
- Product Marketing Specialists
- Design Engineering Managers
- Device Quality Specialists
- Product Documentation Specialists
- Production Managers
- Risk Management Specialists