Medical Device Post Market Surveillance and Vigilance

Post-market surveillance including clinical follow-up, complaint and vigilance handling, impacts on all aspects of the quality management system. Proactive and reactive sources of information are a regulatory requirement to be incorporated in your post-market surveillance procedures applicable to all products. 

This one day course is designed to help you identify the requirements of the European medical device directives (90/385/EEC, 93/42/EEC, 98/79/EC), standards and guidance documents to enable effective implementation of a post market surveillance system.

Unsure if this course is for you? Watch our complimentary taster webinar.

Who should attend?

  • Regulatory professionals
  • Quality managers
  • Clinical affairs specialists
  • Complaint handling specialists
  • Design and development professionals
  • Medical device sales & marketing. 

“The course was delivered in a clear manner and easily understood.”

What will I learn?

On completion of this training, participants will be able to:

  • Confirm the PMS regulatory requirements of the directives required for the particular class of product
  • Create a procedure that includes both proactive and reactive sources of information 
  • Implement cost effective and targeted post-market clinical follow-up using various tools and techniques
  • Recognise when a complaint needs to be reported as an incident

How will I benefit?

By developing a post-market surveillance plan you can target sources of information enabling a cost effective product launch. Obtaining the right post-market information will ensure continued compliance with the directives and identify consumer needs enabling continued product development.

What's included?

  • You will gain 8 CPD points on completing the course
  • Training course notes
  • Lunch
  • Refreshments