At FiunEx, we specialize in guiding medical device and IVD manufacturers to achieve compliance and market access. Our strength lies in our extensive experience and impactful interactions with key regulatory bodies, including the U.S. FDA, Japan's PMDA, Europe's Notified Bodies, China's NMPA, and other international authorities. Many of our team members have previously held positions within these organizations, providing valuable insights for strategic planning.

Our services cover the entire product development spectrum, from inception to post-market support. Whether you need assistance with Notified Body selection, Pre-IDE preparation, or Advisory Panel Meetings, our experienced consultants will craft and execute global regulatory strategies to expedite your commercialization efforts.

FiunEx's approach to medical device quality consulting allows you to maintain control over your projects while accessing external support. Whether you want to enhance in-house capabilities or require specialized expertise, our team is here to help you succeed. Navigating medical device regulations can be challenging, but we're here to streamline your regulatory approval process and ensure compliance with post-market requirements worldwide. Choose FiunEx as your partner, and let's unlock the full potential of your medical devices.