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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

 

Provides a well-defined PMCF Plan template,

 

Review the data entered in the PMCF plan to meet the chosen PMCF objective

 

$ 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)
From the general and specific procedures and methods,

we helps the manufacturer to choose the suitable method or procedure as per the characteristics

and type of their medical devices.

 

Provides a well-defined PMCF study templates.

 

Provides a well-defined PMCF evaluation report template,

 

Verifies the findings and the results based on the PMCF activity chosen by the manufacturer.

PSUR

Benefit-Risk Determination and Conclusion

$ 3000

45 days

  • Benefit – Risk determination
  • Information of usage frequency of the device

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