Summary of Technical Documentation (STED) for Real-Time Polymerase Chain Reaction (PCR) System per EU IVDR 2017/746

A global leader in the medical industry.

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.

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)

Key Tools

SARACA’s proprietary literature record tool
SARACA’s technical file status tracker
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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South Carolina, USA:PO Box 61, Fair Play, South Carolina, 29643

Boston, USA:33 Lyman St, Suite 205, Unit 9, Westborough, Massachusetts, 01581

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Industries

Life Sciences Aerospace and Defense Automotive Semiconductors Industrial Rail Transportation Consumer

Services

Digital IETM SAP Mechanical Embedded Automotive Solutions Software System Manufacturing