This webinar is intended to help you avoid FDA 483s and warning letters for failure to establish and maintain adequate procedures for medical device reporting.
Device manufacturers are required to establish and maintain medical device reporting procedures pursuant to the FDA regulations.
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. To achieve compliance and to remain compliant, it is critical to understand how to define, document and implement the MDR procedure to survive FDA inspections – avoiding FDA 483s and warning letters.
This webinar is aimed at helping device industry understand how to establish and maintain adequate procedures for MDR and further to provide practical and actionable perspectives by increasing awareness and familiarity of the applicable requirements.
In this webinar, you will learn what is required to achieve compliance and stay compliant with MDR regulations.
Areas to be Covered:
Applicable Statues and Regulations
MDR Regulatory Requirements
MDR Standard Operating Procedures (SOPs): Required Elements
Determining and Reporting MDR Events
Reporting Requirements for the User Facilities, Manufacturers, and Importers
Integrating Unique Device Identification (UDI)
Enforcements: Case Studies
Common Mistakes and Consequences
Speaker’s PASS-IT Solutions
Who will Benefit:
A must webinar for all personnel in:
Research & Development
Complaint and Risk Management
Other interested parties