Summary of Technical Documentation (STED) per IVD

A global leader in the Medical industry.

Project Scope

Many Documents to be used in STED are as per IVDD not IVDR
Basic UDI-DI details were not available
For some products previous and/or similar generation of device details are tough to provide

Project Deliverables

IVDR STED
IVDR Appendix 4.1- GSPR( General Safety and Performance requirement)
Technical File Tracker
Technical File Status Tracker
PMS Plan, PSUR, PMSR

Key Tools

Ovid MEDLINE®
PubMed
Scopus
Google Scholar

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.

Get In Touch

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

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 Mechanical Embedded Automotive Solutions Software System Manufacturing IETM