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Post-Market Surveillance - Practical Application for Medical Devices and IVDs In-house Training

Putting the regulatory requirements for post-market surveillance of medical devices and IVDs into a practical perspective

In this practical, one-day course, learn the regulatory requirements needed for successful post-market surveillance of medical devices and IVDs.

★★★★★ "Overall, I found the webinar to be highly informative and well-organized. The content was comprehens... more"

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Course overview

Understanding the regulatory requirements for successful post-market surveillance of medical devices and IVDs is increasingly important and practical application of the regulations is key to a successful PMS system.

This course will provide a clear understanding of the intention of the requirements, and discuss the responsibilities of the manufacturer, notified bodies and competent authorities. It will also provide advice on where to find useful guidance and will include an insight into some possible PMS methodologies for a range of example medical devices and IVD products, including software. 

A review of the reporting and documentation obligations will be included, to enable participants to fully understand and comply with the documentation requirements. 

The regulations for PMS under the MDR and IVDR are complex and this course provides an excellent opportunity to gain essential knowledge, practical application and interpretation of the requirements.

This course is part of our Vigilance training course collection; for information on the basics of PhV, consider taking a look at our beginner-friendly Pharmacovigilance training course.

Benefits of attending

  • Understand the intention of the regulatory requirements for PMS
  • Gain knowledge of the available sources of guidance on the subject of PMS
  • Practice the setting of objectives and criteria for collection of PMS data
  • Explore some possible PMS methodologies for a range of example products covering Medical Devices and IVDs including software
  • Learn the reporting and documentation obligations

Who should attend?

This course will be valuable to those with an existing knowledge of the regulations who are tasked with PMS, but not sure where to start or who have encountered difficulties obtaining PMS data. Personnel in the following roles and departments will benefit:

  • Quality managers within manufacturers
  • Quality associates within manufacturers
  • Regulatory affairs specialists within manufacturers
  • QA/RA responsible people in authorised representatives
  • Person responsible for regulatory compliance (PRRC) within manufacturers & authorised representatives (per Article 15 of MDR/IVDR)

Reviews of IPI's Post-Market Surveillance - Practical Application for Medical Devices and IVDs training course


Overall, I found the webinar to be highly informative and well-organized. The content was comprehensive and relevant, covering key aspects of post-market surveillance for medical devices and IVDs in a clear and understandable manner. The presentation was engaging and well-structured, making complex topics accessible even for beginners like myself. The speakers were knowledgeable and articulate, effectively conveying their expertise and experience. Their willingness to engage with participants and answer questions added significant value to the session. Overall, it was a valuable learning experience that exceeded my expectations.

Jun 6 2024

Ajla Music
Pharmacovigilance Officer, Billev farmacija vzhod d.o.o.

Denmark

  • Billev Pharma
  • Ferring pharmaceuticals
  • Ferring Pharmaceuticals A/S

Italy

  • recordati

Slovenia

  • Billev farmacija vzhod d.o.o.

United Kingdom

  • Genomics plc

Run Post-Market Surveillance - Practical Application for Medical Devices and IVDs Bespoke training for your team

1 day

Typical duration

Pricing from:

  • GBP 500
  • Per attendee, based on 10 attendees
  • Course tailored to your requirements
  • At your choice of location, or online

 

We can customise this course to your requirements and deliver it on an in-house basis for any number of your staff or colleagues.

Contact our in-house training experts Aleksandra Beer and Yesim Nurko to discuss your requirements:

Multiple colleagues? See above for details of our discounts for 2, 3, or 4 delegates. For more, talk to one of our training experts to discuss how to:

Run this course conveniently and cost-effectively in-house for your staff and colleagues

Aleksandra Beer

Aleksandra BEER
Training expert

Yesim Nurko

Yesim NURKO
Training expert

+44 (0)20 7749 4749

inhouse@ipiacademy.com