Post-Market Surveillance (PMS)
Develop a high-level overview of Post-Market Surveillance (PMS) and understand its importance in the lifecycle of a medical device.
Post-Market Surveillance (PMS) is a key aspect of the medical device lifecycle, and it has been made more robust under the MDR (even legacy devices must follow these new requirements).
Once seen as a burden, and dealing mainly with complaints, manufacturers are now seeing the benefit of a well implemented PMS system.
Who will benefit from attending?
This introductory course is appropriate for various key people in the company, including:
Quality Managers, Middle Managers, Quality Engineers, Regulatory Professionals, Sales Teams, Clinical Data Evaluators, Clinical Sponsors, Customer Service Personnel
Course Agenda
This training course introduces the following topics:
Module 1
EU MDR Article 83 and other Post-Market Surveillance (PMS) requirements
Module 2
PMS plan and inputs
Module 3
Proactive and Reactive Approaches
Module 4
Post Market Clinical Follow Up (PMCF)
Module 5
The Periodic Safety Update Report
Module 6
Vigilance and reporting
Module 7
Trend reporting
Module 8
Serious incidents and field safety corrective actions
Learning Objectives
- Understand the EU MDR requirements relating to Post-Market Surveillance and Vigilance
- Summarise the content and principles of the relevant articles and annexes
- Outline the core elements of a PMS and vigilance system
Price
| Single Seat Price |
€75 pp |
|---|
What’s Included?
Access to the Trinzo Training Portal*
Fully interactive course as you work through a case study
Downloadable resources
Knowledge checks
*If there is a preference to embed this course within your global LMS system, we can customise it to match not only your brand, but also your culture and values.
Technology Requirements
Operating system
Windows requirements:
Windows 7 or later
Mac requirements:
Mac OS X Yosemite 10.10 or later
Linux requirements:
64-bit, Ubuntu 14.04+, Debian 8+,openSUSE 13.3+ or Fedora Linux 24+
Processor
Windows requirements:
Intel Pentium 4 or later
Mac requirements:
Intel
Linux requirements:
Intel Pentium 4 or later
Internet Connection
Required
FAQ
Once your booking has been placed and confirmed, you will receive an email which contains your course overview, login details, course agenda and payment receipts. You can begin your training immediately!
On successful completion of the course, you will receive a certificate of completion that can be used to demonstrate your knowledge to your employers and Notified Bodies.
The fastest and easiest way to pay would be to use your company credit card. If you cannot do that, and you require a PO, please email our team at training@trinzo.com.
Yes of course. If you can no longer attend the course, you can transfer your place at no additional cost
Post-Market Surveillance (PMS)
Post-market surveillance consists of activities carried out by manufacturers to gather and assess real-world data on medical devices already on the market, identifying any need for corrective actions. This course presents a high-level overview of the role of post-market surveillance and its importance in the lifecycle of a medical device.
€75