Top 3 Reasons Why Your Medical Device Needs a Clinical Trial
Interpreting evolving regulations for medical devices is a common challenge for emerging biotech companies.
Roundtable: Perspectives on the FDA Guidance for Clinical Decision Software
Clinical decision support (CDS) software is a challenging regulatory space. Conquer the confusion with this roundtable discussion.
Tips for Accelerating Your Medical Device through the Product Lifecycle
Explore the latest strategies to accelerate your medical device throughout the product development lifecycle.
Medical Devices: “Significant Risk” Versus “Nonsignificant Risk” Determinations
Take a closer look at what significant risk and nonsignificant risk determinations mean for medical device clinical trials.
Thorny Issues in Medical Device Research
Learrn how to navigate thorny issues in medical device research, including which regulatory requirements apply to different types of device studies.