Post-Market Surveillance and Vigilance Requirements for Manufacturers (EU 2017/745)
About This eLearning
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
Who Should Attend
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.
By completing/passing this course, you will attain the Medical Device Certificate.