Roadmap to Market Step 6 – Post-Market Surveillance

Roadmap to Market is a training in recognizing basic regulatory vocabulary and introduction to relationships between some regulatory terms & concepts that govern Medical Device manufacture within the EU and US.

With this training (Step 6) you will get more insight in Medical Device Post-Market Surveillance, a systematic process to collect and utilize experience on devices in use, in the field.

There are several courses in this series, take them step by step to become more comfortable in your role as a Regulatory affairs professional:

Step 1 – EU
Step 2 – US
Step 3 – Medical device QMS Introduction
Step 4 – Design and development
Step 5 – Medical Device Software
Step 6 – Post market Surveillance (this course)

Content, Step 6

• 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

Duration: 25 minutes

Course access

Access time: 90 days

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