Post-Market Surveillance - Practical Application for Medical Devices and IVDs
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.
Upcoming start dates
Suitability - Who should attend?
Benefits of attending
Attendees will gain:
- A deep understanding of the intention of the regulatory requirements for PMS
- A knowledge of the available sources of guidance on the subject of PMS
- A chance to practice the setting of objectives and criteria for collection of PMS data
- An insight into some possible PMS methodologies for a range of example products covering Medical Devices and IVDs including software
- A full understanding of the reporting and documentation obligations
Request information - obligation free
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.