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Systems Engineering

Medical device development, systems engineering, product development, quality management, risk management, regulatory compliance, ISO 13485

Desk with paper and computer screen, showing code

Our systems experts look across disciplines and consider multiple approaches and tradeoffs to architect an optimal solution to meet your priorities and constraints. The systems team then stays engaged to ensure the design implementation is consistent with the architected intent.

Our systems engineers apply their decades of MedTech development experience to:

  • Architect and implement robust, maintainable, and extensible designs to support future features
  • Define system and subsystem requirements and designs for medical devices
  • Create fail-safe and fault-tolerant architectures for safety-critical solutions when lives depend on it
  • Apply medical device risk management intelligently to meet your needs without going overboard
  • Win praise from the FDA for providing clear and complete Design History Files (DHF) for our client’s submissions
  • Medical device engineering and medical product development

Meet Our Expert in Systems Engineering

User-centered medical device design in progress

Let’s build your ideas.

Contact us to discuss your product goals and learn how our engineering team can bring your medtech innovation from concept to market.

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Pioneering medical device development and innovation consulting.

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