PER Writing for a Blood Diagnostic Device

Case Study

A global leader in the medical industry.

Case Study Image

Project Scope

  • Ownership for successful external Technical File audit
  • Understanding of the device V&V testing data
  • Executed from offshore to provide cost efficiencies

Project Deliverables

  • The rationale for the frequency of the PER
  • Analytical performance report (APR)
  • Clinical performance report (CPR)
  • Equivalence establishment
  • Justification for the selection of equivalence and size for the testing
  • Execute all the gaps identified
  • Clinical performance studies
  • Peer-reviewed published literature
  • Experience gained through routine testing
  • Content and structure of the Performance Evaluation Report (PER)

Key Tools

  • Ovid MEDLINEยฎ
  • PubMed
  • Scopus
  • Google Scholar
New Delhi, India:

A-18, Bhabha Marg, Sector 59 Noida, Uttar Pradesh, 201301

Bengaluru, India:

78/9, 1ft floor, Vaishnavi Signature, Outer Ring Road, Ballandur Village, Varthur Hobli, Bengaluru Urban, Bengaluru, Karnataka, 560103

Pune, India:

Sr No 133(P), CTS No 4944, Magarpatta Road, Kirtane Baugh, Magarpatta, Hadapsar, Pune, Maharashtra 411013

South Carolina, USA:

PO Box 61, Fair Play, South Carolina, 29643

Delaware, USA:

16192 Coastal Highway, Lewes, Delaware, 19958

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.

Contact Us

Saraca Logo

ยฉ2025 Saraca Solutions Private Limited