Live webcast on Dr.David Lim About Speaker "Implementing a Medical Device Repo
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| Description: | DESCRIPTION This webinar is intended to help you get familiar with the Medical Device Reporting (MDR) pursuant to the Federal Food, Drug, and Cosmetic Act (FD&C Act or the Act). 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 with FDA’s updated MDR requirements, it is critical to understand how to define, document and implement the adequate and sustainable MDR procedures by integrating new requirements. This webinar is aimed at helping device industry understand how to establish MDR procedures and further provide practical and actionable perspectives by increasing awareness and familiarity of the applicable regulatory requirements including integrating a UDI system. This webinar will help you establish and maintain an MDR system in a less burdensome, systematic, and integrated manner including the UDI system integration. Why should you attend : This webinar will provide great opportunities to get familiar with the FDA compliant medical device reporting requirements. Areas Covered in the Session: Statutes and Regulations Definitions Regulatory Requirements for MDR Procedures New MDR Requirements MDR Event Criteria Reporting Foreign Events How to Report A Medical Device Problem (MDR) Reporting Requirements for the User Facilities, Manufacturers, and Importers Relationships with Adverse Event Reporting Systems in EU and Health Canada UDI System Integration Common Mistakes Good Practices: Suggestions and Recommendations Conclusion Who will benefit: (Titles) CEOs VPs Clinical affairs (associates, specialists, managers, directors or VPs) Regulatory affairs (associates, specialists, managers, directors or VPs) Quality professionals (associates, specialists, managers, directors or VPs) R&D (engineers, scientists, managers, directors or VPs) Complaint and risk management personnel Consultants Anyone interested in the topics Webinar Includes: Q/A Session with the Expert to ask your question PDF print only copy of PowerPoint slides 60 Minutes Live Presentation Certificate of Attendance |
| URL: | https://www.compliance2go.com/product/?pid=CP2014-289 |
| Date: | Wednesday, May 7, 2014 |
| Access: | Public |
| Created by: | Public Access |
| Updated: | Wednesday, March 19, 2014 1:11pm UTC |
| : | $189 |
| : | (877) 782-4696 |
| : | subscribec2go@gmail.com |
| : | Compliance2go |
| : | 8777824696 |
| Comments: | None |