Roadmap to Market Step 6 - Post-Market Surveillance
Roadmap to Market Step 6 - Post-Market Surveillance
Basic Level | Course | English | Medical Device | 25 minutes
Corresponds to 2 hours of teacher-directed learning
Description
This is a training in Medical Device Post-Market Surveillance, a systematic process to collect and utilize experience on devices in use, in the field.
Content
- Understand the purpose of Post-Market Surveillance
- How to write a Post-Market Surveillance plan
- What is PMCF and PMPF, and how does it relate to PMS?
- How to document the results
- Know which actions to take, based on the results
Course modules
0. Introduction
In this module you will get to know what Post-Market Surveillance is and what the content of those 6 training modules will cover.
Duration: 2 minutes (Total duration of the course: 25 minutes)1. What is PMS, and why do we need it?
In this module I will present the reasons for why Post-Market Surveillance is so important, and what the data collected during Post-Market Surveillance shall be used for.
Trainer: Åse Ek
Duration: 3 minutes (Total duration of the course: 25 minutes)
2. Post-Market Surveillance PLAN
In this module we will look more closely into the planning aspects of Post-Market Surveillance and how to define relevant objectives for your PMS activities.
Trainer: Åse Ek
Duration: 5 minutes (Total duration of the course: 25 minutes)
3. Post-Market Clinical Follow-Up
In this module we’re looking into the activities entitled “Post-Market Clinical Follow-up”. This is surveillance of devices in the field, with the aim to generate data, to update the clinical evaluation.
Trainer: Åse Ek
Duration: 7 minutes (Total duration of the course: 25 minutes)
4. DO! Execute & document
This module addresses the execution of the planned PMS activities, and the documentation of the outcome, i.e writing the Post-Market Surveillance Report, and PSUR.
Trainer: Åse Ek
Duration: 3 minutes (Total duration of the course: 25 minutes)
5. Actions to take, based on PMS output
This module points to the actions that need to be taken, based on the outcome of the Post-Market Surveillance, including assessment for Vigilance reporting requirements, but as you know by now, there are also many other objectives that need to be met.
Trainer: Åse Ek
Duration: 3 minutes (Total duration of the course: 25 minutes)
6. Summary
A couple of words to summarise and connect back to the learning objectives.
Trainer: Åse Ek
Duration: 2 minutes (Total duration of the course: 25 minutes)
Course material
There is no additional course material for this course.
Notes
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Training organisation
Key2Compliance AB
Key2Compliance AB is an independent international organization providing its training and services to a variety of functions in the Life Science industry, from development to market in terms of Quality Systems and Regulatory compliance.
By helping organizations to comply with regulatory expectations, to enhance workforce knowledge and motivation and to promote a correct attitude towards quality, we believe we contribute to the supply of safe health care products - and in a wider perspective we save lives.
Trainer
Åse Ek - Senior consultant
Åse Ek is a senior consultant and trainer in medical device regulations and quality systems. Åse has over 20 years’ experience in the medical device industry and is specialized in risk management, quality systems and post-market surveillance.
The course results in a diploma that shows that you have the skills required.
All prices shown exclude VAT.
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Online education is faster than traditional education. We make the same courses and content accessible in just under a third of the time normally required.
The efficiency gain is due to the fact that there are no lunch breaks, no commute, no group discussions, and no breaks. However, the total time spent teaching always remains intact.
1 h - Equivalent to a half-day course
2 h - Equivalent to an all-day course
4 h - Equivalent to a 2-day course
6 h - Equivalent to a 3-day course
Please note that the duration specified does not include time for breaks or revision. Don't forget to set aside time for any workshops and time to take the tests of the course, which is required to earn a diploma.
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