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About Unitron Regulatory

Unitron Regulatory is the right partner for product certification in the field of medical devices and life-science devices. Our team has specialist knowledge and practical experience with regard to product certification (CE, MDD/MDR, IVDD/IVDR, LVD, FDA, etc.) of medical and life-science electronic products and equipment. We are experts in the field of building up a technical product file and product life cycle management.

Our expertise

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 mission

Unitron Regulatory aims to fulfill your need for a reliable advice and support partner for medical and life-science devices, with extensive hands-on experience in product certification within the European Union and beyond.

Our values

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 focus

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.

More information

If you are interested with what types of technologies we have in-house or want to read what our customers think about Unitron, visit the Unitron website, where you can find a lot of extra information about where the Unitron Regulatory team comes from. Also follow Unitron on LinkedIn for regular updates regarding Unitron’s activities and medical device certification insights.

Go to Unitron Group Website