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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

PMSData 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