About Unitron Regulatory

Unitron Regulatory is part of Unitron. Unitron is a reliable partner for the development and production of medical and complex industrial electronic products. Our customers are companies in the medical, life-science and industrial sectors, scaling from start-ups to multinationals, who want a partner for the (re)design, development, production, or certification of an electronic product. Having this practical development, production and certification experience in the field of medical and life-science equipment makes our expertise unique.

Our advice and support is personal, honest and lean. It is our mission and passion to help you find your way in the regulatory landscape of medical and life-science devices, and have your product on the market as fast as possible.

Our customers usually come to Unitron for the development stage (focused on developing a new product) or for the design transfer stage (focused on producing an existing or new market-worthy product). During both stages, construction and assessment of the Technical File, the Risk Management File, the Design History File and the submission file for certification is required. Unitron Regulatory has the specific knowledge for this in-house and aims to simplify and speed up the assessment of this information in order to get products into production and on the market faster. Unitron Regulatory offers their services regardless of any development or production expectations, but always with focus on your product.