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 […]
Developing safety-critical medical devices is a complex process that requires careful planning, rigorous testing, and cross-functional collaboration. The stakes are high—not only because of regulatory and market risks but also because patient safety depends on every design decision. Below, we explore key strategies that can help ensure the success of safety-critical medical device development. Understanding […]
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 […]
Transforming Healthcare with Connected Medical Devices
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
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 presentation empowers you with the knowledge to design effectively with stepper motors