Both medical products and many non-medical products must comply with European and international legislation in order to be allowed to be sold. Each product is unique in its kind and requires a specific regulatory approach. Our Unitron Regulatory department is ready to support you with all your questions regarding certification, from developing a complete regulatory strategy to compiling a quality management system or technical documentation set.
Want to know more? See our Unitron Regulatory website www.unitronregulatory.nl
Download our readable version of the Medical Device Regulation
Our quality system complies with ISO 13485, Ordinance 169 and FDA. This means that we can produce for the European, as well as for the Japanese and American markets. In addition, our production department works according to the requirements of IPC-A-610D Class 2. In short: we have all the relevant certificates and in-house knowledge to comply with the stringent medical regulations.Want to know more? Please get in contact with us