Advancing Diagnostic Technologies for Precision & Care
In Vitro Diagnostics Medical Device Technologies
In Vitro Diagnostics (IVD) industry is experiencing a dynamic transformation driven by leading-edge software technologies and innovative advancements. This evolution is not just about enhanced capabilities; it’s about redefining patient care through smarter, more efficient diagnostic solutions.
We, at Saraca Solutions, embrace the technological breakthroughs in industry and navigate the rapidly transforming global regulations and international standards, ensuring that our customers meet the highest quality and safety benchmarks.
Our Service Offerings
Performance Evaluation Plan (PEP)
Performance Evaluation Report (PER)
Scientific Validity Report (SVR)
Clinical Performance Report (CPR)
Analytical Performance Report (APR)
Summary of Safety and Performance (SSP)
Case Studies
Case Study 1: Summary of Technical Documentation (STED) for Real-Time Polymerase Chain Reaction (PCR) System per EU IVDR 2017/746
Project Scope: To develop a technical documentation for the class C Real-Time Polymerase Chain Reaction (PCR) System intended for the detection of cancer screening.
Approach and Methodology:
- Developed new templates compliant with EU IVDR 2017/746, from documents per the IVDD.
- Re-classification of Real-Time Polymerase Chain Reaction (PCR) System per EU IVDR 2017/746 Annex VIII.
- Identified applicable GSPRs per EU IVDR 2017/746 and developed a plan to comply with the requirements.
- Performed gap analysis of provided analytical studies per the requirements of EU IVDR 2017/746 for the Analytical Performance Report (APR).
- Performed searches to identify the relevant published clinical data on the subject device for the Clinical Performance Report (CPR) and Scientific Validity Report (SVR).
- Weighing and appraisal of clinical data on the subject and similar device.
- Evaluated the adequacy of clinical data for the demonstration of safety and efficacy for the Real-Time Polymerase Chain Reaction (PCR) System.
- Conducted risk assessment of all reported events for subject and similar device in literature database, publicly available vigilance databases, and data held by the manufacturer to identify emerging risks.
- Created PMS plan and report per IVDR 2017/746 Annex III.
- Performed qualitative and quantitative analysis of clinical data to support the safety and performance.
- Re-defined the acceptance criteria with analysis of scientific literature and clinical studies.
Tools & Databases Used:
- SARACA’s proprietary literature record tool
- SARACA’s technical file status tracker
- Literature database: PubMed, Google Scholar, and Ovid MEDLINE
Project Deliverables:
- Summary of Technical Documentation (STED) per IVDR 2017/746
- GSPR checklist
- Post Market Surveillance (PMS) Plan, Periodic Safety Update Report (PSUR)
- Post Market Performance Follow-up (PMPF) Plan and Report
- Performance Evaluation Plan and Report (PEP/PER)
Case Study 2: Performance Evaluation Report (PER) for the MGIT Mycobacterial Detection System
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
Approach and Methodology:
- Identified the applicable GSPRs requirement necessary for the device to ensure its safety and performance.
- Defined the objectives with their endpoints and established the acceptance criteria based on the similar devices for evaluating the performance of MGIT mycobacterial detection system.
- Developed a performance evaluation plan in compliance with IVDR requirements to assess the safety and performance of MGIT mycobacterial detection system.
- Performed gap analysis of provided analytical studies per the requirements of EU IVDR 2017/746 for the Analytical Performance Report (APR).
- Performed searches to identify the relevant published clinical data on the subject device for the Clinical Performance Report (CPR) and Scientific Validity Report (SVR).
- Performed Qualitative and Quantitative benefit-risk analysis to identify emerging risks for Performance Evaluation Report (PER).
- Created a detailed overview of state of the art that provides a review of the current and emerging technologies related to the device under evaluation.
- Drafted Performance Evaluation Report from the outcomes of the Analytical Performance Report (APR), Clinical Performance Report (CPR), and Scientific Validity Report (SVR).
Tools & Databases Used:
- SARACA’s proprietary literature record tool
- Literature database: PubMed, Google Scholar, and Ovid MEDLINE
Project Deliverables:
- Performance Evaluation Plan and Report (PEP/PER)
- Analytical Performance Report (APR)
- Clinical Performance Report (CPR)
- Scientific Validity Report (SVR)
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