At Asphalion, we’re dedicating this week to showcasing the importance of MedTech. Our team of MedTech consultants, integrated together with our pharmaceutical and scientific consultancy services, can keep you ahead of market challenges and help you meet all regulatory and quality requirements.
We’re kicking off MedTech Week by showcasing how Asphalion supported a client facing a critical regulatory challenge. After receiving a suspension letter from their Notified Body due to unresolved non-conformities, the client’s CE-marked medical device was at risk of losing market access in the EU. Simultaneously, the company aimed to enter the U.S. market but lacked the internal resources and regulatory expertise to navigate the complex FDA clearance process. Through coordinated EU and U.S. regulatory support, our team helped the client address the non-conformities, regain compliance, and strategically advance toward FDA submission, ensuring continued global market presence.
Join us as we dive into best practices, regulatory updates, and expert insights throughout the week—including our Webinar “Pre-clinical Testing Requirements under Regulation (EU) 2017/745 on Medical Devices: A Notified Body’s Perspective “, as well as valuable resources designed to support the development and compliance strategies of your MedicalDevices.
Need help navigating your MedTech strategy? Get in touch with us!: [email protected]
Check out our success case here: MEDTECH WEEK SUCCESS CASE
