test Medical Technology and Healthcare

EXPLORE OUR DIVERSE PORTFOLIO OF MEDTECH SERVICES

We help global MedTech OEMs accelerate time-to-time market, mitigate regulatory risks, improve clinical outcomes and enhance patient experience through value-based partnerships with them. Our key strengths include an agile, process driven execution model, capable of managing demand variability and unlocking cost-efficiencies for our clients. As a valued partner to the medical devices industry for 10+ years, we offer services from concept to commercialization.

Our service portfolio

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Product Development and Sustaining

  • Design concepts to prototype solutions
  • Design & development – embedded H/W & S/W, mechanical systems
  • Verification & Validation
  • Packaging & labeling design
  • Simulation – FEA/CFD
  • Sustaining engineering
  • VAVE
  • Technical publications
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Manufacturing Engineering

  • Process planning & layout design
  • Plant engineering
  • Process validation (IQ, PQ, OQ)
  • Test fixtures design
  • Controls & automation
  • Supplier quality management
  • Failure analysis, CAPA
  • Drawings & manufacturing documentation support
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Regulatory Compliance

  • Regulatory submissions support – FDA, CE, other regions
  • Tech file gap analysis & remediation
  • MDR/IVDR transition support
  • Clinical/Performance evaluation reporting
  • Post-market surveillance support
  • Environmental compliance – RoHS, REACH
  • Regulatory packaging, labeling, IFU compliance
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Digital

  • IoT integration & connected products development
  • Cloud enablement & DevOps support
  • Data Analytics & visualization
  • AI/ML
  • Application development & maintenance (desktop, web, mobile)
  • S/W test automation
  • Product security services