The landscape of medical device cybersecurity has officially changed. The transition from a framework based on “shoulds” to one defined by “musts” has raised the bar for regulatory compliance, security rigor, and patient safety. The FDA’s updated guidance on cybersecurity in medical devices. At Suntra MedTech, we are proud to announce that our Secure Product […]

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 […]

Bringing a new medical device to market is a complex and high-stakes endeavor. Companies face numerous challenges, from securing funding and managing product development to navigating stringent regulatory requirements. Success requires a strategic approach, combining innovation with disciplined execution. 1. Identifying the Right Problem to Solve One of the biggest factors in MedTech success is […]

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

Navigate Key Risks to Bring Your Product Vision to Life Every new product comes with risks—are you prepared? Learn how to navigate the challenges of new product development with our whitepaper, “New Product Development: Managing the Risks”. For additional perspective beyond this risk-management whitepaper, explore The Keys to Medical Device Project Success. This related POV […]

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.

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

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

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

Behavioral interventions are techniques to help shape thoughts and actions so people may achieve goals and reach desired outcomes