This course will review the Medical Device Tracking Regulations as they relate to the manufacturer of medical devices, including what types of devices require tracking, what types of devices do not require tracking, and what type of information is required to be obtained and maintained by the manufacturer. We will discuss different methods than can be utilized to track patients and/or devices. In addition, we will discuss the relationship between Medical Device Tracking, Medical Device Reporting, and Medical Device Recalls.
- Explain the necessity for Medical Device Tracking
- Discuss the Manufacturer obligations to Medical Device Tracking
- Determine what methods of tracking should be utilized and when they should be utilized
- Discuss the relationship between Medical Device Tracking and Medical Device Reporting
- New Quality Personnel responsible for Device Tracking
- Regulatory Affairs Personnel responsible for submitting safety reports to FDA and other health authorities
- Medical Affairs Personnel responsible for safety-related decisions regarding product labeling, regulatory interactions, or customer communication
- Clinical Research Professionals involved with medical device trials and adverse event reporting
Douglas Albrecht, B.S.N., C.C.R.A.
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Hold this course at your company! For more information, contact Naila Ganatra at +1 215.413.2471.