2023 - The design was the leading cause of the most serious medical device recalls in 2022

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