Humidification Class II medical device designed to moisten air and control humidity

By meticulously reviewing the original product and approach, the Sunrise team was able to leverage learnings to develop an ergonomic solution that incorporated readily available, low-cost technologies that meet rigorous cybersecurity standards. This strategy directly addressed Pro2Health’s needs for affordability and user-friendliness.

In the rapidly evolving landscape of medical device development, risk management is a fundamental process that ensures patient safety and regulatory compliance. An effective risk management strategy not only identifies potential hazards early but also streamlines development by reducing costly redesigns and regulatory hurdles. Understanding Risk Management Risk management, as defined by ISO 14971, is […]

The 2025 Cybersecurity Checklist from Sunrise Labs provides a clear roadmap for integrating cybersecurity best practices throughout medical device development

Sunrise Labs offers a comprehensive approach to managing cybersecurity risks as part of a development program

In the rapidly evolving landscape of software development, Continuous Integration and Continuous Deployment (CI/CD) have emerged as pivotal practices, especially within the medical device industry. These methodologies are not just buzzwords; they are revolutionizing the way we approach medical device development, offering a beacon of efficiency and reliability in a sector where precision and quality are non-negotiable.

Teams who develop medical products must develop a deep understanding of the underlying physiology as well as the use and misuse challenges related

This checklist is intended to capture the major activities necessary for a successful program with the appropriate expertise needed to guide design tradeoffs from concept to launch and beyond in the most efficient manner possible

This presentation empowers you with the knowledge to design effectively with stepper motors

Sunrise Labs offers a comprehensive assessment to mitigate cybersecurity risks for new medical devices and those that already exist on the market.

Design Verification of Medical Devices can be overwhelming. One of the simplest, most effective techniques is just to have someone else check your work.

Some challenges and considerations related to product architectures that might include Machine Learning