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.
Do you want to bring a medical product to market? Obtaining your own certification can be a difficult and time-consuming task. That is why we offer you the possibility to launch your product under our quality system. For this, you only have to meet a couple of requirements.Want to know more? Please get in contact with us