Medical Device Development

Comprehensive support for innovative medical device development and regulatory approval

Medical Device Innovation

Oracle BioTech provides end-to-end support for medical device development from concept to commercialization, including regulatory strategy, clinical trials, and quality systems.

Medical Technology

Digital Health Solutions

Development of digital therapeutics, mobile health apps, and AI-powered diagnostic tools for improved patient care.

  • Digital therapeutics platforms
  • AI diagnostic algorithms
  • Remote monitoring devices
  • Telemedicine solutions
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Diagnostic Equipment

Diagnostic Devices

Advanced diagnostic equipment and point-of-care testing solutions for rapid and accurate disease detection.

  • Point-of-care diagnostics
  • Laboratory automation
  • Imaging technologies
  • Biomarker detection systems
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Device Development Process

Concept

Design Phase

Device concept development and feasibility assessment.

Prototype

Development

Prototype development and proof-of-concept testing.

Preclinical

Testing

Bench testing and animal studies for safety validation.

Clinical

Trials

Human clinical studies for safety and efficacy.

Approval

FDA/CE Mark

Regulatory submission and market approval.