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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	PMS planning PMS period Select the sources from our PMS Plan provided by us. Risk Management File with all residual risks Customer Feed back Sales History and Sales volume data User Feedback in our template. Vigilance and CAPAs if any Reactive source – Clinical Literature Review (CER)
	PMCF study will be decided based on risk and device classification
	Preparation of PMS report with the manufacturer’s support*

PMCF	Support in selection of device for PMCF	$ 2000 30 days	Set PMCF Plan PMCF period selection in line with the PMS Identify List of Study Centers Clinical Investigators Method of PMCF study based on Consultants Inputs Analysis & Conclusion based on the study ( by the evaluator)
	PMCF Evaluation Report

PSUR	Benefit-Risk Determination and Conclusion	$ 3000 45 days	Benefit – Risk determination Information of usage frequency of the device