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.

Unitron Regulatory is part of the Unitron Group. At Unitron Group we create high-technology life-science products. From design to prototype, and from certification to serial production. We have been doing this for global players in the medical sector for more than 30 years. Our strength lies in complex mechatronic and electronic equipment. Based on the very latest technology, we develop life-science devices that matter. In areas such as anaesthesia, ophthalmology, oncology and diagnostics.