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.

• 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.

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

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

Vanessa Rivel has 15 years of experience in the medical device sector. Her background includes regulatory affairs, quality systems, auditing, and training. Currently, she works as an independent consultant. Her past work experience includes roles as a Quality Systems Engineer at Hospira, Quality Transfer Engineer at Boston Scientific, Site Quality Manager at  Sterigenics, and Quality Systems Manager at Precision Concepts Group. She has completed her Meng in Industrial Engineering and MBA In Marketing and Licentiate in Chemistry. She holds a certificate for Regulatory Affairs Certified (RAC), Certified Lead Auditor ISO 13485 (Exemplar Global), Certified Manager of Quality / Organizational Excellence (ASQ), Certified Quality Engineer (ASQ), Certified Six Sigma Green Belt (ASQ), Medical Device Master Auditor (ASQ), and Certified Quality Auditor (ASQ),