Medical device manufacturers are subject to medical device reporting for device-related adverse events and malfunctions including record-keeping requirements.
This webinar is intended to help you adequately establish and maintain medical device reporting procedures and practices and also to further help you avoid FDA 483s and warning letters.
In the United States, 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 what to consider and 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 implement best practices and stay compliant with statutory requirements and MDR regulations.
- Applicable Statues and Regulations
- MDR Regulatory Requirements
- MDR Standard Operating Procedures (SOPs): Required Elements
- MDR Criteria
- Determining and Reporting MDR Events
- Reporting Requirements for the User Facilities, Manufacturers, and Importers
- Enforcements: Case Studies
- Common Mistakes and Consequences
- Best Practices
- Speaker’s PASS-IT Solutions
- Clinical Affairs
- Regulatory Affairs
- Complaint and Risk Management Personnel
- Senior Management
- Other interested parties