CLEIO is a North American and ISO 13485-certified Medical Device Development Company, delivering end-to-end design, engineering, and software support from early concept through to FDA clearance.
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CLEIO is an end-to-end medical device development company that brings regulated products to market through integrated design, engineering, software and quality services.
Since 2005, our 60+ in-house experts have completed 2,500+ projects for 300+ partners, from early-stage startups to established large enterprises, working in an ISO 13485-certified environment built for FDA, Health Canada and EU MDR review.
Because strategy, human factors, design, engineering and quality sit under one roof, you get one accountable team rather than a chain of vendors. Ranked among the top five product development firms in North America, we work as an extension of yours, sharing the decisions, the risk and the results.
CLEIO brings design, engineering, software, and quality together as a single, integrated medical device development team operating within one ISO 13485-certified quality management system.
Quality Management System
Risk Management
Software Lifecycle for Medical Device
Electrical Safety for Medical Electrical Equipment
Usability Engineering for Medical Device
Explore medical innovations we’ve worked on.
Our largest project yet. We designed and engineered the Polartrak, a proprietary and revolutionary medical device developed by Starpax Biopharma to treat cancer.
We have collaborated with Soundbite Medical to design and develop the latest commercial version of their medical device.
Design and engineering of an innovative home-use patient monitoring sensor to track incontinence.
4.6 / 5 Stars Customer Satisfaction Rating
Working with CLEIO has been an outstanding experience. Their seamless integration with our internal resources has greatly enhanced our approach to product design, always prioritizing the patient and their unique needs. The team's exceptional communication, effective project management, and technical expertise across the board have made every collaboration smooth and impactful. CLEIO's ability to bring innovative solutions while maintaining efficiency has truly set them apart, making them an invaluable partner in our efforts to create meaningful, patient-centric designs.
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 resources 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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