Unitron Regulatory: here to help you with your certification

All medical and many non-medical products must comply with European and international legislation before they are approved for sale.

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

Downloads & Certificates

Download our readable version of the Medical Device Regulation

Download our ISO 13485 certificate Download our Ordinance 169 certificate Download our Electronic instructions for use (EU) 2021/2226 Readable edition

All the required certificates and in-house knowledge

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

Moving forward together

We are happy to share our extensive and specialist knowledge. Because we’re convinced that this will enable us to add more value to the healthcare sector.

Watch our full story