In an era of advancing medical technology, patient-centric design has emerged as a cornerstone in the development of medical devices. This approach emphasizes creating devices that prioritize the needs, preferences, and experiences of the patients they serve. Coupled with an evolving regulatory landscape, patient-centricity is transforming the healthcare ecosystem. Patrick John Gora emphasizes that by… Continue reading Patient-Centric Design in Medical Devices: A Regulatory Perspective
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Digital Health Trends: Regulatory Insights for Remote Monitoring Devices
The healthcare industry has been revolutionized by the advent of digital health technologies, with remote monitoring devices standing at the forefront of this transformation. These devices—ranging from wearable fitness trackers to sophisticated medical-grade tools—are changing the way patients and providers approach care. However, alongside this innovation comes a complex web of regulatory requirements that developers… Continue reading Digital Health Trends: Regulatory Insights for Remote Monitoring Devices
Implementing Effective Quality Systems Under EU Medical Device Regulation (EU MDR)
The essential components of a compliant quality system, and practical tips for aligning existing quality systems with the new requirements to ensure ongoing compliance.