Performance Evaluation Report (PER) for the MGIT Mycobacterial Detection System

Case Study

A global leader in the medical industry.

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Project Scope

To develop performance evaluation report for MGIT mycobacterial detection system intended for the susceptibility testing of Mycobacterium tuberculosis per EU IVDR 2017/746

Project Deliverables

  • Performance Evaluation Plan and Report (PEP/PER)
  • Analytical Performance Report (APR)
  • Clinical Performance Report (CPR)
  • Scientific Validity Report (SVR)

Key Tools

  • SARACA’s proprietary literature record tool
  • Literature database: PubMed, Google Scholar, and Ovid MEDLINE

About Us

SARACA is a rapidly growing product engineering services company with deep expertise in digital, artificial intelligence, and emerging new technologies. Founded in 2014, SARACA is powered by Gen Z and Millennials with greater focus on agility, customer centricity, faster technology adoption, and adherence to cultural sensitivity. Our digital natives perform their actions with speed and ensure that we exceed customer expectation every single time. SARACA adopted vertically integrated approach to build depth in the industries we operate in. Over the years we have built strong expertise in aerospace, defense, space, automotive, medical devices, Industrial, Farm Equipment, rail transportation, technology, semiconductor, and many other industries.

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New Delhi, India:A-18, Bhabha Marg, Sector 59 Noida, Uttar Pradesh, 201301
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Industries

Life SciencesAerospace and DefenseAutomotiveSemiconductorsIndustrialRail TransportationConsumer

Services

DigitalIETMSAPMechanicalEmbeddedAutomotive SolutionsSoftwareSystemManufacturing
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