This article focuses on practical strategies for medical device companies to strengthen their quality management systems and ...

From blood pressure cuffs to glucose monitors and pulse oximeters, remote patient monitoring solutions have emerged as a game ...

Historically, many medtech companies have engaged with the FDA in a conservative way, providing only the minimum required to ...

Legacy medical devices remain in use despite outdated security. Manufacturers must apply structured, risk-informed strategies ...

Choosing the right micro molding partner is critical for high-precision industries. Success depends on early collaboration, ...

Legacy medical devices pose growing cybersecurity and regulatory risks. Manufacturers need structured, risk-informed ...

FDA warning letters highlight recurring patterns, systemic gaps, and evolving priorities that medical device manufacturers ...

The digital revolution that resulted in the IoT, IoMT, SaMD, and connected devices comes with the possibility of cyberattacks. The FDAs latest efforts to enhance medical device cybersecurity include a ...

This article explains why Latin Americas demographic diversity, cost profile, and accelerating digital health infrastructure ...

New safety-certified MLCCs with up to 500 Vrms rating, compact design, and harsh-environment resilience deliver reliable high ...

Over the past decade, the Supreme Court has made the formerly simple analysis of patent eligibility for diagnostic technologies into a complex mixture of hard-to-reconcile precedents. However, after a ...