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PMS+PMCF+ PSUR+Writing Fees
We can help you with PMS activities as per MDR Article 83, 84, 85 & 86
ACTIVITY |
CONSULTANT SCOPE OF WORK |
FEES |
INPUTS FROM CLIENT |
PMS | Data collection and Analysis based on the reactive and proactive sources selected by the manufacturer. |
$ 3000 40 Days |
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PMCF study will be decided based on risk and device classification |
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Preparation of PMS report with the manufacturer’s support* | |||
PMCF |
Support in selection of device for PMCF |
$ 2000 30 days |
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PMCF Evaluation Report |
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PSUR |
Benefit-Risk Determination and Conclusion |
$ 3000 45 days |
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