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.
Upcoming start dates
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
Customer Outreach Award
We believe that it should be easy for you to find and compare training courses.
Our Customer Outreach Award is presented to trusted providers who are excellent at responding to enquiries, making your search quicker, more efficient and easier, too.
Expenses
Multiple participant and early bird booking discounts available. Discounts also offered to NHS staff, regulators and charities.