We explore the key differences between design verification and design validation, =their importance, and best practices.
Month: January 2025
Key Steps for Building a Robust Quality Management System (QMS) from Scratch
A well-implemented QMS is a strategic asset that helps your organization stay competitive and thrive in the long term.
Patient-Centric Design in Medical Devices: A Regulatory Perspective
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
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