A Systems Approach for efficient and compliant design and development of Medical Devices What are you trying to build? How will you define “success”? How will the product be used? Do you know how to test the product? How will the architecture be organized? What do you need for regulatory clearance or approval? This whitepaper […]

Supporting over 30 client medical product development projects a year gives us a broad perspective and provides the opportunity to share key takeaways

What the security vulnerability means for Bluetooth-enabled medical devices and how Sunrise Labs’ risk management process pre-emptively minimized or eliminated the risks.

A set of Bluetooth LE vulnerabilities, collectively known as SweynTooth, brought attention to some straightforward attack vectors.

Sunrise Labs has prepared an outline of the medical device business, development, and regulatory efforts required for the commercialization process.

We have transitioned into an unprecedented landscape of remote work, here are some suggestions for staying user-centered.

Learn how to make your Human Factors (HF) usability studies less chaotic by investing in a small amount of planning and keeping some guidelines in mind

There are several benefits associated with prototyping early in the design process

This article explores some of the benefits and challenges related to the connectivity of medical devices to external networks and provides an overview of how to address many of these challenges.

Medical device software, real-time software, embedded systems, software development, reliability, safety, regulatory compliance

Download this whitepaper to learn how systems engineering can help you optimize your medical device development process, improve quality, and reduce risks

Integrating technology readiness reviews into the product development process enables actionable processes that reduce project risk.