Course Description:
It is essential to have an effective, efficient and robust medical device post market surveillance system.
This two day interactive seminar will focus on:
-Complaint Management
-Medical Device Reporting (MDR)
-EU Vigilance Reporting
-Product Recalls
These are key elements for early identification and rapid response to problems with marketed products. In addition to the obvious need to comply with regulatory requirements, it is also vital from a business standpoint to understand the importance of complaint management, MDR's, vigilance reporting and product recalls. A robust post market surveillance system helps to prevent unnecessary patient injuries, reduces the chances for financial loss, and it could result in improved products.
Complaint management, MDRs, EU vigilance reporting, and product recalls are top priorities in FDA and notified body inspections. For example, 40% of all FDA Warning Letters are related to issues involving the complaint management system. Additionally, four recent Warning Letters issued by the FDA involved issues related to MDRs.
This course will provide practical guidance and real life examples that will help you develop and/or optimize your company's post market surveillance system.
It is essential to have an effective, efficient and robust medical device post market surveillance system.
This two day interactive seminar will focus on:
-Complaint Management
-Medical Device Reporting (MDR)
-EU Vigilance Reporting
-Product Recalls
These are key elements for early identification and rapid response to problems with marketed products. In addition to the obvious need to comply with regulatory requirements, it is also vital from a business standpoint to understand the importance of complaint management, MDR's, vigilance reporting and product recalls. A robust post market surveillance system helps to prevent unnecessary patient injuries, reduces the chances for financial loss, and it could result in improved products.
Complaint management, MDRs, EU vigilance reporting, and product recalls are top priorities in FDA and notified body inspections. For example, 40% of all FDA Warning Letters are related to issues involving the complaint management system. Additionally, four recent Warning Letters issued by the FDA involved issues related to MDRs.
This course will provide practical guidance and real life examples that will help you develop and/or optimize your company's post market surveillance system.
