Post-market surveillance for manufacturers is covered in Articles 83-86. Articles 87-89 cover post-market vigilance requirements. This course reviews the requirements set forth in these articles in detail, with expert advice provided throughout the course.
By the end of this course you should be able to:
- Recognize the layout and utility of specific sections, articles and annexes of the EU MDR.
- Identify where manufacturers can locate detailed information on developing a post market surveillance system, plan and reports.
- Identify where manufacturers can locate detailed information on vigilance requirements including the reporting of serious incidents and field safety corrective actions (FSCAs).
- Recognize the responsibilities of manufacturers in trend reporting and analysis of serous incidents and FSCAs.
By completing/passing this course, you will attain the certificate Medical Device Certificate
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