Voler Systems specializes in designing a wide range of medical devices, spanning from Class 1 to Class 3. We are well-versed in navigating FDA requirements, CE requirements, and regulations across various countries worldwide. Our dedicated team collaborates closely with clients throughout the entire process, from initial requirement assessment and risk analysis to the development of prototypes and rigorous verification testing. This comprehensive approach guarantees that the final product is primed for seamless transition to manufacturing. Additionally, we offer support in establishing partnerships with quality and regulatory experts, as well as manufacturing collaborators.
View the video below for further insights.