Transition of CER for Wound Healing Device from MDD to MDR

Case Study

A global leader in the Medical industry.

Case Study Image

Project Scope

  • A lot of articles returned from literature searches
  • Developed new appraisal criteria to include the most relevant articles
  • Including approx. 30 articles and written summaries for all of them
  • In detail, clinical data analysis for all the summary and incorporated to CER
  • Developed a claim matrix with all their clinical and technical claims and endpoints

Project Deliverables

  • CEP (Clinical Evaluation Plan)
  • CER (Clinical Evaluation Report)
  • Equivalent device table
  • Searches for both S&P and SOA
  • Vigilance data searches 
  • Complaint data

Key Tools

  • SARACAโ€™s proprietary AiSummaryโ„ข Tool.
  • Microsoft word and excel
  • Cochrane, Embase

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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