Understanding of latest FDA guidance requirements and expectations related to medical device tracking and what are the new changes.This medical device tracking webinar training will address the latest FDA guidance requirements and expectations and expound on why and what are the information, the tracking methods must provide about the location of a tracked device. We will also discuss the role and responsibilities and the impact with user facilities and patient issues.
Areas Covered in the Seminar:
Review the key provisions in the updated FDA guidance on medical device tracking.
Understand the regulatory expectations for device tracking.
Identify new terms and criteria.
Understand the statutory criteria and what changed.
who are required to track various implantable devices - FDA has issued orders to manufacturers
What are the additional guidance factors to be considered when determining whether a tracking order should be issued
Understand why tracking methods are subject to FDA inspection
When does tracking end?
Identify what information to report and your responsibilities
Understand the impact with user facilities and patient issues
Who Will Benefit:
This webinar will provide an overview and guidance to device manufacturers involved in medical device tracking activities. Employees who will benefit include:
All levels of management and departmental representatives and those who desire a better understanding or a "refresh" overview of the Medical Device Tracking process and FDA s latest expectations
Regulatory Affairs
Clinical Affairs
Quality and Compliance
Marketing & Sales
Distributors/Authorized Representatives
Consultants
Past Events
Webinar on Medical Device Tracking 2011 - 10 Feb 2011, Webinar (12726)
Webinar on Medical Device Tracking 2026
Important
Please, check "Webinar on Medical Device Tracking" official website for possible changes, before making any traveling arrangements