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 websiteDownload 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 usWe 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 storyWhere do the opportunities for increasing our success lie? And how can we manage the hype cycles of developments of innovative medical devices?
In this whitepaper, we will talk you through our expertise. Because by sharing knowledge, we can grow together. Opportunities that boost success
Unitron Systems B.V.
+31 (0)117 307 300
info@unitron.nl
Unitron Regulatory
+31 (0)117 307 300
regulatory@unitron.nl
Unitron Systems BVBA
+32 (0)9 397 1860
info@unitron.nl
Schansestraat 7-9
4515 RN IJzendijke
GOOGLE MAPS
Asveldweg 2
7556 BP Hengelo
GOOGLE MAPS
Poortakkerstraat 35B
9051 Gent
GOOGLE MAPS
© 2023 Unitron Group B.V.
