Why regulatory and quality due-diligence is often overlooked.
Complexity of design and frequency of use play a large role in how effectively scopes are reprocessed.
Tips from industry peers who are going through the process.
The agency calls out specific devices that should include human factors data in premarket submissions, along with recommendations for combination products.
Via partnerships with pharmaceutical companies, Insulet expands its platform technology past insulin delivery.
Shift the odds in your favor.
A guide to a risk-based CAPA program for device manufacturers.
Industry shifts focus to proactive measures in addressing vulnerabilities and promoting cybersecurity.
FDA simply won’t tolerate extreme claims outside a product’s cleared or approved use.
As the incidence of GI conditions grows, device companies in this segment should explore expansion in the region.