Course description
Post Market Surveillance and Vigilance Requirements
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
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 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.
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.