The Hippocratic Oath and its famous dictum, “First, do no harm” (primum non nocere), have been part of the medical world for centuries, a telling sign of medicine’s long-standing commitment to prioritizing the welfare of the patient.  But what it meant to “first, do no harm” back in the day when care was dictated almost […]

In emergency medicine, minutes matter. But behind every “rapid response” clinical innovation is years of disciplined systems thinking, engineering rigor, and regulatory foresight. One of the most complex challenges facing trauma care today isn’t treatment, it’s access. Plasma, a critical component in emergency transfusions, has traditionally been constrained by freezing, storage, transport logistics, and slow […]

FrontlineODP™ is an on-demand plasma system designed to spray-dry human plasma for reliable storage, transport, and use compared to frozen plasma.

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.