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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.

Start the conversation today.

How We've Helped Clients with their Systems Engineering Needs

Learn More About Our Systems Engineering Expertise Through Our Insights

Webinars & Events About Systems Engineering

Benefits of systems Engineering Approach

The Benefits of a Systems Engineering Approach: How to Reduce Risks & Improve Performance in Medical Device Development

Past Event: January 20, 2022 12:00 pm

This Suntra webinar explored how a holistic Systems Engineering approach drives the creation of commercially successful, user-focused medical devices. Speakers shared how systems engineers unite technical disciplines, streamline complex development programs, and balance innovation with business goals to deliver next-generation healthcare solutions.

Systems Engineering

Systems Engineering for Medical Device Development

Past Event: February 15, 2018 12:00 pm

In this Suntra webinar, experts demonstrated how Systems Engineering drives success in complex medical device programs. The session explored how early integration, clear requirements, and disciplined processes improve performance, predictability, and regulatory compliance—turning multifaceted development efforts into commercially viable healthcare solutions.

Pioneering medical device development and innovation consulting.

Let’s start a conversation today.

Learn how our engineering team can bring your medtech innovation from concept to market.

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