Next-Biomed supports the development of next-generation, minimally invasive medical devices by combining engineering, regulatory strategy, and clinical planning into a structured and reliable pathway to market.
We are shaping the future of minimally invasive medicine through advanced technologies in different medical fields, delivering safer procedures, better outcomes, and a higher quality of life for patients around the world.
Our mission is to advance healthcare by supporting startups and companies in developing innovative medical devices through comprehensive R&D, patenting, regulatory, and clinical strategies — ensuring safe and efficient access to the market.
Next-Biomed provides expert design development, evaluation and optimization for medical devices, including implantables, integrating engineering and regulatory risk assessment to accelerate certification (CE and FDA) and market readiness.
Next-Biomed provide end-to-end product development and regulatory support for early-stage medical device companies or SME, helping streamline development, navigate regulatory pathways, and improve the chances of securing funding and reaching the market faster.
Next-Biomed designs clinical investigation protocols and reports, and in general clinical documentation for devices in development or already certified (post-commercialization surveillance).
Next-Biomed supports both venture capital and private equity firms in conducting technical and regulatory Due Diligence, as well as companies preparing for and undergoing due diligence processes, with a strong focus on regulatory strategy.
Next-Biomed provides structured project management for medical device development, integrating design, regulatory, and clinical activities into a clear development timeline. We also support founders in preparing business plans and P&L models for investor presentations.
Next-Biomed supports companies in preparing technical, business, and financial materials for fundraising activities and grant applications. We assist in identifying subsidized financing opportunities and in preparing proposals aligned with project development and regulatory strategies.
Next-biomed supports patenting strategies for innovative medical device ideas, including drafting of patent applications and the preparation of patent drawings.
Next-Biomed offers comprehensive support in the development, prototyping, and preclinical assembly of implantable devices, including those incorporating biological tissues.
We provide clients with dedicated engineering support embedded within their projects, complemented by mentorship and strategic guidance.
Next-Biomed announces a new partnership with MedTech to combine complementary expertise and support medical device companies from concept to market, addressing technical, clinical and regulatory challenges. The collaboration aims to foster innovation, share knowledge and create new opportunities for medical device development.
