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Recorded Webinar
FDA Compliant Practices for Medical Device Reporting (MDR), Recall, Correction and Removals
timelapse 60 mins with 10-15 mins of Q and A
Note:
This webinar occured in the past
Along with recorded webinar, copy of presentation slides will be shared
Recorded Webinar can be played unlimited times
Speaker/Presenter
Short Abstract
In the United States, since December 13, 1984, the Food and Drug Administration (FDA) Medical Device Reporting (MDR) regulations have required firms who have received complaints of device malfunctions, serious injuries or deaths associated with medical devices to notify FDA of the incident. MDR is the mechanism for the FDA to receive significant medical device adverse events from manufacturers, importers and user facilities, so they can be detected and corrected quickly. Device firms are also subject to compliance to the FDA regulations of device recalls, correction and removals. To achieve compliance and to remain compliant, it is critical to understand how to define, document and implement the procedures for MDR, recalls, corrections and removals.
This webinar is aimed at helping device industry understand how to establish procedures for MDR, recalls, corrections and removals and further provide practical and actionable perspectives by increasing awareness and familiarity of the regulatory requirements.
At the end of the webinar, you will get empowered in a way that you would plan, develop and execute the relevant procedures efficiently and effectively.
The presentation will cover the following areas:
- Relevant Statutes and FDA regulations.
- Regulatory Requirements for MDR, Recall, Correction and Removal.
- Definitions.
- How to Report A Medical Device Problem (MDR).
- Reporting Requirements for the User Facilities, Manufacturers, and Importers.
- Recalls, Corrections and Removals (Devices).
- Voluntary Recalls and Mandatory Device Recalls.
- Corrections and Removals.
- Enforcements: Case Studies.
Who should attend
Anyone who is interested in learning more on FDA Medical Device Regulations
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