When: |
02 Dec through 02 Dec 2020 | |
Where: |
Online Event | United States | |
Website URL: |
https://www.complianceonline.com/statistical-elements-pmcf-seminar-training-80660SEM-prdsm?channel=Brownwalker | |
Sponsoring organization: |
Compliance Online | |
Categories: |
Engineering & Technology - Chemical |
Keywords:
Event description:
The EU MDR 2017/745 includes new standards for CE marking of devices in the EU, one of the new standards is for the development and execution of a Post Marketing Clinical Follow-up plan. (PMCF).
PMCF is a continuous process that updates the clinical evaluation and shall be addressed in the manufacturer’s post market surveillance plan. When conducting PMCF, the manufacturer should proactively collect and evaluate clinical data from the use in or on humans of a device which bears the CE marking and is placed on the market with the aim of confirming the safety and performance throughout the expected lifetime of the device, of ensuring the continued acceptability of identified risks and of detecting emerging risks on the basis of factual evidence.
PMCF shall be performed pursuant to a documented method laid down in a PMCF plan. The focus of this seminar is to provide the statistical understanding and information needed to design and report a post-market clinical follow-up (PMCF) s...
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Posting date:
26 November 2020 | 157 views
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