We are a ISO 13485 Medical Product Development Firm.

Next

We Excel At _____________.

  • Product Strategy & Roadmapping
  • Ethnographic Research | Usability 
  • Industrial Design 
  • UI/UX Design 
  • Mechanical Engineering 
  • Firmware & Electronics Development 
  • Prototyping
  • Safety, Electrical, & Environmental Product Testing 
  • Design for Manufacturing & Assembly
  • Contract Assembly & Production Coordination
Next

Medical Devices are Consumer Devices.

All products should delight. We meld the design thinking of consumer products with the rigour of medical device development. We consider all stakeholders when designing a product, balancing requirements of go-to-market cost, reimbursement, product architecture, and regulatory strategy/requirements. Our depth of in-house product development experience is supported by a trusted network of advisors who help clarify go-to-market challenges of medical devices.

Next

Design Controls. By Designers. For Designers.

Bringing a new medical device to market is the opposite of user-centered design. We questioned the status quo and built a proprietary ISO 13485 Quality Management System that accelerates medical device time to market. Conceptual design drives requirements in early project stages, then requirements drive engineering, prototyping and testing as the product is fully commercialized. This flexibility allows us to uncover novel solutions in early product phases and brings formality to build all design control documentation required for market submission.

Next

Our Design Outputs. Your Submission.

A new medical device is more than just a new product, it’s also testing & documentation that proves to regulatory bodies that the device has been verified and validated, meets user needs and provides safe and effective treatment. As we develop your device, we build the required Design History File, or DHF, that is critical to your product’s successful market authorization.

Back to top
Ready to take the next step?

Advance your Medical Device with Cortex Design.

Patients are demanding more of their healthcare experience- we help your product meet that demand.
Let's Get in Touch!

© 2024 Cortex Design Inc.