We are ISO 13485 certified. It means that our development process for medical devices is fully compliant with the high expectations of the FDA and other healthcare organizations. For you, it’s the assurance that your idea is in good hands.
ISO 13485:2016
ISO 14971:2019
IEC 62304:2006/AMD1:2015
IEC 60601-1 Ed. 3.2
Our ISO-13485 certification means that our development activities are controlled and structured by audited and certified processes. These ensure our service quality and the satisfaction of our customers.
300+ Customers
With the support of CLEIO, we are more confident than ever in the decisions made. All members of the CLEIO team are great experts and professionals, covering a broad spectrum of aspects that a medical device project needs. They approach their work with pleasure, dedication, and motivation.
To undertake ambitious large-scale projects, choosing the right partners is essential. The CLEIO team leverages its expertise and ingenuity, and mobilizes passion and ressources as a partner in developing our groundbreaking cancer treatment technology.
In addition to their expertise, CLEIO provided us with excellent communication throughout the entire process. They also made the most of every minute of our strict timeline. Working with CLEIO has ensured a solid foundation for future product development.
Working with CLEIO allowed us to quickly show investors a certified, effective, well-designed, and attractive ready-to-market medical device that addresses critical human factors in a hospital environment. We’re moving forward with additional certification and collaborating with our CLEIO team on the next phase of development.
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