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U.S. FDA Medical Device Complaint Handling and Servicing – Plus ISO 13485:2016 Requirements

NSF International
Training overview
1.5 hours
299.99 USD
English
Next start date: Inquire for more information - Online

Course description

U.S. FDA Medical Device Complaint Handling and Servicing – Plus ISO 13485:2016 Requirements

Maintaining proper complaint files is an essential element of the medical device quality management system. This course examines the importance of a properly functioning complaint handling system and the relationship between complaints, service reports, U.S. medical device reporting and CAPA. It provides a side-by-side comparison of the U.S. complaint handling requirements to the ISO 13485:2016 standard.

Training Content

Objectives

By the end of this module you will be able to:

  • Differentiate between FDA and ISO 13485:2016 requirements
  • Identify the structure of a functioning complaint handling system
  • Recognize when events related to servicing activities represent complaints
  • Describe the relationship between complaint handling, service reports, and Corrective and Preventive Action (CAPA)

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Certification / Credits

Certificate

By completing/passing this course, you will attain the certificate Medical Device Certificate

About supplier

NSF International

NSF International

NSF Health Sciences partners with life science companies, big and small, to provide highly customized end-to-end services throughout the product lifecycle. From early development to commercial manufacture and distribution, our expert services will assist you to: Ensure regulatory compliance Implement...


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