Events

• A recall is one of the most feared scenarios in the medical devices industry.
• The FDA posts information summaries about the most serious medical device recall on its web page.
• These are all classes I recall, an event in which the use of the device will cause serious adverse health consequences or death.
• Sixty serious recalls were on the FDA list in 2022.  22% of the recalls (13 of 60) were due to the device's design.

WHY SHOULD YOU ATTEND?

 
Learning the most frequent causes of medical device recalls can serve as a reference to compare the state of compliance in our organizations.

AREA COVERED

• FDA regulations for medical device recalls
• FDA medical device recall classification 
• The most frequent causes for recalls for medical devices in 2022
• Trends in recalls for the past five years (2018-2022)
• Sub-systems on the Quality Management System that caused the majority of serious recalls in 2022
• Critical requirements of those sub-systems and how to maintain compliance

LEARNING OBJECTIVES

• Identifying FDA regulations for medical device recalls
• Learning the FDA medical device recall classification 
• Identifying the most frequent causes of recalls for medical device companies in 2022
• Identifying the trends in recalls for the past five years (2018-2022)
• Identifying the sub-systems of the Quality Management System that caused the majority of serious recalls in 2022
• Identifying the critical requirements of those sub-systems and how to maintain compliance.

WHO WILL BENEFIT?

• Quality Director
• Site Quality Manager
• Quality Systems Manager
• Quality Systems Specialist
• Quality Systems Technician
• Internal Audits Manager