FDA Inspection Readiness (5 Course Bundle)

This course bundle provides 5 eLearning courses and 18 hours of training to prepare you and your team for FDA Medical Device Inspection. Each course includes focused content developed by medical device experts experienced in conducting and managing FDA Inspections; knowledge checks to keep the learner engaged; and a final competency assessment at the end of each course. An Individual Certificate of Successful Completion is provided for each of the 5 courses.

Courses in this bundle include:

• FDA Medical Device QS Regulation and Inspection Technique (QSIT)
• FDA Medical Device Reporting Requirements
• ISO 14971:2019 Application of Risk Management to Medical Devices
• Medical Device Complaint Handling and Servicing
• Design Controls for Medical Devices and IVDs