The medical device development process goes through five phases and comprises various steps and procedures to ensure the safety and efficacy of the device.

The future of healthcare is being shaped by incredible advancements in medical device product development. From wearable monitoring devices to cutting-edge diagnostic tools, innovation is revolutionizing the way we approach healthcare. These developments are enabling personalized medicine, enhancing patient outcomes, and improving the efficiency of healthcare delivery. In this article, we will explore the latest […]

Hosted by AdvaMed, this Suntra-led webinar brought together industry experts to discuss the challenges of developing safety-critical medical devices. The panel shared real-world insights on balancing innovation with regulatory and quality demands—offering guidance for teams advancing next-generation medical technologies.

In this joint MassMEDIC and Suntra webinar, experts explored how a systems-based approach strengthens medical device cybersecurity amid evolving threats and regulatory changes. The discussion highlighted strategies for integrating cybersecurity into risk management, improving post-market monitoring, and building long-term resilience across connected health technologies.

Misaligned stakeholders can delay projects and increase costs. In this MassMEDIC and Suntra webinar, we explore practical ways to align teams around a shared understanding of the Risk Management Process—clarifying key terms, improving communication, and building a foundation for effective, compliant risk management.

Having a “Eureka!” moment and coming up with a new idea is only the first step in a lengthy and sometimes tedious process known as medical device development.. David Hibbard of Sunrise Labs has worked in medical technology development for over 25 years, so David knows a thing or two about navigating this process. In today’s […]

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

This Suntra webinar explored how a holistic Systems Engineering approach drives the creation of commercially successful, user-focused medical devices. Speakers shared how systems engineers unite technical disciplines, streamline complex development programs, and balance innovation with business goals to deliver next-generation healthcare solutions.

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

Sunrise designs user-friendly medical devices into commercial products by keeping the patient–not their infirmity–at the forefront.

What factors do you need to think about when building connected devices?

Agile methodology offers a more flexible approach and allows requirements to evolve to a more optimum solution for medical device development