Post Market Surveillance and Vigilance Requirements for Manufacturers (EU 2017 745)
5
What you'll gain from this course
Learn anytime on any device
Interactive modules and knowledge checks
Certificate available upon completion
Our instructors review the requirements of post-market surveillance (Articles 83-86) and post-market vigilance (Articles 87-89), and provide expert advice for manufacturers throughout the course.
Key learning objectives:
By the end of this course, you will be able to:
- Recognize the layout and utility of specific sections, articles and annexes of the EU MDR
- Identify where to locate detailed information on developing a post-market surveillance system, plan and reports
- Identify where to 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 serious incidents and FSCAs
This post-market surveillance training is helpful for all medical device professionals and management and executive personnel looking to expand their knowledge on the EU MDR.
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