Novosanis is ISO13485 certified by SGS Belgium. Our quality system is thereby fully compliant with the requirements of ISO13485 quality standards for manufacturers of medical devices.
“Receiving the ISO13485 certificate is a true reward for the team’s effort and commitment to produce both platforms, Colli-Pee and VAX-ID, according to best practice. It is an objective recognition that allows customers and stakeholders to gain trust in what the Novosanis team offers which is very motivating for the entire team.” said Timothi Van Mulder, Quality Manager at Novosanis.
Novosanis' Colli-Pee device is CE-marked and FDA listed.
We have registrated trademarks® in the following countries:
- Colli-Pee®: European Union (EU), United States (US), Mexico (Mexico), China (CN), Japan (JP) and Korea (KR).
- VAX-ID®: European Union (EU) and United States (US)
- Novosanis®: European Union (EU)
- UCM®: European Union (EU) and United States (US)
Registration for other countries and continents is ongoing. Novosanis is in the process of obtaining CE for its VAX-ID non-prefilled drug delivery device.