Your guide to navigating the complexities of US FDA 510(k) submissions and taking your medical device from concept to regulatory clearance.
Learn about the FDA's ISO 10993 standard and how it applies to medical device manufacturers.
Learn how to navigate the medical device development process from concept to commercialization.
Many of the best ideas are born on those difficult days when surgical cases present unique challenges.
Feasibility studies are a critical step in the medical device development process.
Surgeons are uniquely positioned to identify unmet needs in the operating room and develop solutions to address them.
Developing a medical device is a complex process that requires a significant investment of time and money.