Every product is unique and requires a specific regulatory approach. Our Unitron Regulatory division 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
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 not only the European market, but also for 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 stringent medical regulations.Want to know more? Please get in contact with us