Medical Device Safety & Reporting Summit – Medical Device Safety & Reporting Summit

The FDA receives a significant amount of medical device-related investigations that have caused harm or had a serious malfunction and is a topic that should not be overlooked. In order to properly navigate through the obstacles of medical device regulations, sponsor organizations must identify specific reports for adverse events related to the device and also relay any safety issues in regards to the device. In a world where technology is changing very frequently, it is equally as important to keep up with emerging trends and advancements that shape how these guidelines are set in order to properly report and track them.

Whether it is an oxygen mask, nebulizer, cardiovascular stent, medical imaging equipment, or robotics, there are certain requirements that each device must meet before going to market. While these medical devices are paramount when providing care to patients, they occasionally fail to operate OR are misused causing further harm to the patient or even death, which makes risk assessment an important juncture when developing a medical device. All parties that are involved during the life cycle (government, manufacturer, vendor, user facilities) of the medical device must be transparent, and communication is key in order to reduce risk and further advance into the marketplace.

Medical device reports can provide valuable information and act as a surveillance system. However, there are limitations as to the submissions that are not accurate or incomplete. When dealing with postmarket surveillance data, it is critical to streamline the implementation processes for these regulations and reports. Industry professionals in regulatory affairs, compliance, postmarket surveillance must work together to determine the successful implementation of certain strategies to assess risk and uncover best practices to follow the guidelines set forth by the FDA.

Top Five Reasons to Attend

  1. Ensure medical devices meet proper regulatory requirements and the highest quality standards
  2. Benchmark best practices and guidelines for medical device monitoring and safety with a post-approval surveillance strategy
  3. Recognize future regulation implications and ensure a successful risk management plan
  4. Allow patients to access high-quality devices with innovative strategies to maintain compliance with the FDA
  5. Understand essential elements of an effective CAPA system while maintaining compliance with reporting and documentation processes to avoid regulatory issues

Who Should Attend

  • Quality Management
  • Clinical Quality Management
  • Quality Assurance
  • Regulatory Affairs
  • Medical Affairs
  • Medical Device
  • Risk Assessment
  • Compliance/Ethics
  • Monitoring
  • Site Management
  • Site Quality
  • Research and Development
  • Project Management
  • Pharmacovigilance
  • Safety
  • Data Management
  • Real-World Evidence
  • Adverse Events/Case Management Service Providers
  • Safety Database Providers

This conference is also of interest to:

  • Healthcare/Pharmacovigilance Consultants
  • Technology Vendors
  • CROs
Startdate: 2019-03-25
End Date 2019-03-26

Description: The Medical Device Safety & Reporting Summit will provide attendees with critical information about the importance to maintain the quality of your medical device and ensure valuable risk management plans to further advance into the marketplace without having any setbacks.
Performer: ExL Events
Address : Medical Device Safety & Reporting Summit