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Our Services

End-to-End Performance Evaluation Services

Overview

Performance Evaluation

We support development of performance evidence demonstrating safety and effectiveness of your IVD device under IVDR.

Our Approach

Evidence Mapping

  • Identify existing data
  • Define gaps in scientific, analytical, and clinical evidence
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Planning

  • Performance Evaluation Plan (PEP)
  • Study and literature strategy
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Data Generation / Compilation

  • Analytical performance data
  • Clinical performance data
  • Literature review
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Analysis

  • Data interpretation
  • Risk-benefit evaluation
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Documentation

  • Performance Evaluation Report (PER)
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Deliverables

  • PEP and PER
  • Literature review report
  • Evidence gap analysis
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Outcome

Strong performance evidence aligned with IVDR expectations.

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Structured IVDR Advisory. Precision in Every Submission.

Quick Links

Head Office Address

2002, Eleganzo, GB Road, Thane (W)

Days Open

Monday - Friday 09 AM - 06 PM

Contact

+91 91365 97231

Email

info@vermed.in

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