From the earliest stages of development, we actively contribute our regulatory expertise. We perform device qualification and classification and define the corresponding regulatory strategy. Throughout the development process, we are an integral part of the project team—interpreting regulatory requirements, conducting reviews, and preparing regulatory submission files. We also support interactions with regulatory authorities to ensure alignment. In the post-market phase, we assist with change control management, lifecycle maintenance, and adaptation to evolving regulatory requirements, ensuring long-term compliance and sustained market access.

By integrating regulatory input from the outset and leveraging proven platforms, we ensure submission readiness for both combination products and our own medical devices. Our teams contribute to design verification reports, human factors documentation, and technical files in alignment with global regulatory expectations. This proactive approach streamlines the submission process, minimizes the risk of late-stage revisions or delays, and enables smooth navigation through complex requirements, ultimately accelerating the product’s time to market.