Post Market Surveillance and Vigilance Requirements for Manufacturers (EU 2017 745)

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.