Blogs

What AI Can — and Cannot — Do in Regulated MedTech
December 12, 2025
What AI Can — and Cannot — Do in Regulated MedTech

AI is transforming MedTech engineering—but only when applied responsibly. In an industry where patient safety, regulatory compliance, and auditability

AI MedTech FDA AI Engineering AI in Healthcare Regulated Engineering
Quality Management System Regulation (QMSR) - What’s Changing in Medical Device Regulation
December 09, 2025
Quality Management System Regulation (QMSR) - What’s Changing in Medical Device Regulation

February 2, 2026. This date marks a regulatory milestone that will reshape how medical device manufacturers approach quality management, documentation, and desi

Healthcare Medical Devices Medical Device Regulation Quality Assurance in Healthcare QMSR FDA Quality Assurance
Building the Foundations of a Modern, Connected Healthcare Ecosystem
November 28, 2025
Building the Foundations of a Modern, Connected Healthcare Ecosystem

Healthcare is undergoing one of the most profound transformations in its history. The challenges are unmistakable—rising costs, aging populations, chronic dis

Medical Device Digital Healthcare Connected Healthcare Smart Medical Devices Remote Monitoring HealthTech
Human-Centred Medical Device Design for Modern Medical Environment
November 12, 2025
Human-Centred Medical Device Design for Modern Medical Environment

Safety is the most important priority in the medical device industry across the world. Over the last few years or so, a new approach called human-centred design

Medical Devices Medical Engineering Healthcare Innovation Healthcare UX Usability Engineering
IoT Security in US Healthcare: Balancing HIPAA Compliance and Medical Device Innovation
October 10, 2025
IoT Security in US Healthcare: Balancing HIPAA Compliance and Medical Device Innovation

What happens when the hunger for IoT-driven breakthroughs in healthcare runs headfirst into HIPAA’s unbending rules? That’s the urgent and delicate puzzle U

IoT Healthcare IoT security Digital Heathcare Healthcare IoT IoMT Medical Device Digital Healthcare HIPAA
Multidisciplinary Engineering Capabilities in Medical Device Design and Engineering
September 15, 2025
Multidisciplinary Engineering Capabilities in Medical Device Design and Engineering

Design and engineering of medical devices is a multifaceted field that requires skills in various fields of engineering. The process of developing safe, effecti

Product Development Medical Devices Digital Heathcare Medical Engineering Medical Technology Healthcare Technology
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