Expert guidance on medical device regulation, compliance, and industry best practices.
Early engagement with the FDA can shape the success or failure of a medical device submission long before a 510(k), De Novo, or PMA is filed. Learn how to use Pre-Sub and Q-Sub programs strategically.
Bringing a medical device to market does not end with FDA authorization. For manufacturers seeking hospital adoption, reimbursement strategy often becomes the next critical bottleneck.
The FDA’s Electronic Submission Template and Resource (eSTAR) has fundamentally changed how 510(k) submissions are prepared. Learn how to navigate it effectively.
Regulatory pathway selection, device classification, and predicate strategy determine everything that follows. Learn how to approach these foundational decisions.