Guides/Clinical and post-market

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Clinical and post-market

Clinical evidence and post-market follow-up: literature reviews, clinical evaluation, PMS, PMCF and PSUR.

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Clinical evidence and post-market follow-up: literature reviews, clinical evaluation, PMS, PMCF and PSUR. Clinical evaluation, post-market surveillance, PMCF and PSUR.

What you'll see

1
Clinical and post-market: the evidence that the device is safe and performs.
2
Literature Reviews record what was searched, screened and included.
3
Clinical Evaluations bring the clinical evidence together.
4
The evaluation states the scope, the data and the conclusion.
5
Benefit-Risk Analyses weigh the benefits against the remaining risks.
6
Post-market surveillance: the plan and the reports that follow it.
7
PMCF plans and reports cover clinical follow-up after launch.
8
PSUR reports summarise safety and performance for each period.
9
Customer Satisfaction Surveys add the user's voice.

The screens show sample data for a fictional company, Nordic MedTech Oy. Captions are on screen and available as a CC track.

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