Built for

The future of medical device development

Why does Ultralight matter for innovative medical devices?

Even the best medical device teams lose precious time, money, and team morale trying to stay compliant during the design & development phases.

Our solution makes it easy to handle requirements & risk management, end-to-end traceability, and related compliance activities in a single, lightweight platform that’s optimized for the speed of modern device development.

We're building the single source of truth for your product data

How it works

Design Control built for engineers

  • Multi-level requirements management
  • Fast filtering and search
  • Seamless generation of records

Risk Management simplified

  • Source of truth for all risk activities
  • Mitigations tied to Design Control
  • ISO 14971 compliant

Document Management that's consumer-grade

  • Centralized digital repository
  • Modern approvals workflows
  • FDA Part 11 compliant signatures

Design Control built for engineers

  • Multi-level requirements management
  • Fast filtering and search
  • Seamless generation of records

Risk Management simplified

  • Source of truth for all risk activities
  • Mitigations tied to Design Control
  • ISO 14971 compliant

Document Management that's consumer-grade

  • Centralized digital repository
  • Modern approvals workflows
  • FDA Part 11 compliant signatures

Traceability that puts Excel to shame

  • Lightning-fast traceability views
  • End-to-end visibility across your product
  • Actionable insights about product statuses

Design Control built for engineers

Risk Management simplified

Document Management that's consumer-grade

Design Control built for engineers

Risk Management simplified

Document Management that's consumer-grade

Traceability

The Ultralight difference

Do More With Less

  • Save your team’s time for value add activities
  • Spend less money on expensive consultants

Design Better Products

  • Work within contextualized design tools built for engineers
  • Automatically document design data in an intuitive way

Ensure Compliance

  • Leverage simplified regulatory frameworks
  • Implement an FDA / ISO compliant quality system

Tailored to the fast-changing med tech industry.

We’ve worked with highly experienced operators from engineering, quality, and regulatory to create a highly intuitive and lightning fast system that works for all stakeholders.

Ready to get started?

Fill out the form and one of our experts will reach out to schedule a demo!

We’re on a mission to accelerate medical device innovation by streamlining critical operational workflows.

Join Our Newsletter

Copyright © 2023 Ultralight Labs. All Rights Reserved.

What people say!

Dictumst eget facilisis aliquam gravida id eget feugiat placerat. Vulputate vitae amet neque quisque. A, amet phare

Lorem Ipsum

5/5

Ipsum mattis at vivamus metus eu auctor sit. Et ipsum in pulvinar nisl orci quis adipiscing quis odio massa praesent neque Congue

testi-1.jpg
John Doe
Business

Lorem Ipsum

5/5

Ipsum mattis at vivamus metus eu auctor sit. Et ipsum in pulvinar nisl orci quis adipiscing quis odio massa praesent neque Congue

testi-2.jpg
Jane Doe
Business