Welcome to the MEDEVICE blog. Here we share expert perspectives on medical device development, combination products, regulatory strategy, and quality management.
Stay tuned for in-depth articles on:
– Navigating FDA combination product regulations
– Best practices for Design History File (DHF) creation and remediation
– Risk management per ISO 14971:2019
– Human factors engineering for medical devices
– Grant writing strategies for NIH SBIR/STTR funding
– Career development in the medical device industry
Our team of practitioners brings decades of hands-on experience from the front lines of FDA-regulated product development. We write about what we know, from real projects and real challenges.
Contact us to suggest topics or contribute your own perspective.