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Medical Device Complaint Handling and Servicing

NSF International, Health Sciences
Course summary
1.5 hours
300 USD excl. VAT
English
Online courses
Next available date: Enquire about this self-paced eLearning course - Online courses

Course description

Medical Device Complaint Handling and Servicing

Maintaining proper Complaint files is an essential element of the medical device quality management system. This course will examine the importance of a properly functioning complaint handling system. Once medical devices reach the market, clinicians and others may experience deficiencies related to the identity, quality, durability, reliability, safety, usability, effectiveness, or performance of the device. These deficiencies may cause or contribute to a number of adverse events, including events that meet prescribed thresholds for adverse event reporting to regulatory authorities, including U.S. FDA Medical Device Reports (MDRs). This course will examine these reasons and help explain the important of a functioning complaint handling system and the relationship between complaints, service reports and CAPA.

Note:

Due to the video nature of this course, we recommend taking the course in Google Chrome for optimal performance.

Outcome / Qualification etc.

Certificate

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

Training Course Content

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)

Why choose NSF International, Health Sciences

Trained over 1,300 delegates on our CQI and IRCA certified GMP PQS lead auditor training course

Provided expert health sciences training for over 30 years

More people have become ‘Qualified Persons’ in Europe through our training programme than any other training provider

Expenses

Multiple participant and early bird booking discounts available. Discounts also offered to NHS staff, regulators and charities.

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About provider

NSF International, Health Sciences

NSF International provides training and education services for leading organisations in the health care industries. Our health sciences courses have one objective – to bring about change that drives improvements in your workplace. Known globally for high-quality content, we are...


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Contact info

NSF International, Health Sciences

The Georgian House, 22/24 West End
Kirkbymoorside
YO62 6AF York

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