Archive: Medical Device Tracking

August 18, 2010 | Barnett International Recording

Web Seminar Archives are available in either USB Flash Drive or DVD Format.

Archives are also available in SCORM format for LMS integration. Please contact Barnett at (215) 413-2471 for more details and pricing on SCORM files.

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$735.00

Course Description

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.

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Learning Objectives

  • 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

Who Should Attend

  • 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

Instructor

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.