Medical Device Engineering Services

Intelligent | Connected | Future Ready

PRODUCT ENGINEERING


Launching Superior Products in the Market

  • End-to-end product development support by industry experts
  • Digital technology integration for enabling various use cases
  • Improving Device Reliability, Performance and Safety

  • Mission-critical module development for medium-high risk devices
  • Comprehensive V&V for sub-system and system quality assurance
  • Sustaining Products in the Market

  • Post-market engineering support services for longer product lifecycle
  • Proactive compliance with latest regulatory standards
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    VALUE ANALYSIS & VALUE ENGINEERING


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    Product-line Extension

  • Launch technologically advanced and safer devices for improved clinical outcomes
  • Targeting New Markets

  • Identify usage gaps through consumer research
  • Align product cost in accordance with the target market needs
  • Extending Product Lifecycle and End-of-Life Support

  • Revisiting high revenue generating product portfolio for cost optimization and complying with the latest regulatory requirements

  • VERIFICATION & VALIDATION


    Reduce Time-to-Market

  • A specialized team with experience in 21 CFR Part 820
  • Flexible onsite-offshore support model
  • Automating the V&V Process

  • Advanced and automated V&V tools to facilitate thorough testing against product and/or functional requirements, maintaining complete traceability across the project lifecycle
  • Comprehensive and Reliable V&V Program

  • Dedicated test infrastructure and customized test environment to ensure product quality throughout its lifecycle
  • Explicit and intensive execution of design verification and validation process vis-à-vis intended use
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    AI/ML IN MEDICAL IMAGING AND HEALTHCARE


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    Launch Exciting Usecases for the Future

  • Glean more information from radiology images through enhancements and analytics
  • Development and integration of modules to enable decision support system in existing imaging application workflow
  • Intelligence at your Disposal

  • Deploy platform agnostic solutions - from cloud to embedded devices on the edge
  • Monetizing the Investments in AI

  • Enable pay-per-use service and term licenses for advanced diagnostics

  • SAS FRAMEWORK FOR EU MDR/IVDR COMPLIANCE


    Retain and Gain Additional Market Share

    Ensure EU MDR/IVDR compliance well within the timeline with:

  • Agile-based implementation for high deliverable throughput
  • Re-usable MDR assets focused on first-time-right concept
  • Ecosystem of internationally accredited testing partners
  • Comprehensive Program Oversight Fostering Function-wise Collaboration

  • Centralized program management for flexible sprint planning to efficiently handle a high volume of implementation work
  • Contain Increasing Cost of Quality

  • Multiple offshore cross-functional scrum teams for parallel implementation minimizing stress on the bottom-line
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    CLINICAL EVALUATION REPORT WRITING


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    CER Creation for Newly Classified and Up-classified Devices

  • Data collection, analysis and interpretation to create EU MDR compliant CERs
  • Rigorous Post-market Oversight to Ensure Product Continuation

  • Preparing periodic post-market clinical follow-ups and safety update reports to align with the EU MDR requirements
  • Access to Skilled Cross-functional Professionals

  • A diverse team of medical writers, clinical data evaluators, system engineers and physicians/surgeons (MD)
  • Proactive compliance with latest regulatory standards
  • Contact Us

    Name:   Gaurav Singh

    Phone:   +1 (908) 547 7748