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

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)