All-in-One Medical Design, Engineering & Software Development Expertise

CLEIO specializes in Strategy, Human Factors, Design, and Engineering for Medical Devices. With ISO 13485-certified processes and a multidisciplinary team, we transform innovative ideas into safe, effective, and user-centered products—accelerating development while ensuring compliance and market readiness.

Launch Your Medical Device with Confidence – Our Experts Are Here to Help

To be successfully launched on the market, a medical device must not only be functional. It must also fill a need and meet regulatory requirements. We help you develop your innovation from your initial idea or from an existing product to be improved.

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.

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Design and Engineering of Innovative Solutions in the MedTech & Healthcare Industry

Partnering with CLEIO gives you expert guidance in planning design and development activities, ensuring alignment with industry standards and regulatory requirements.

Digital Health & Monitoring

Therapeutic Devices

Diagnostic & Imaging Tools

Specialized Systems

Our Quality Management Process Follows the Highest Development Standards

ISO 13485:2016

ISO 14971:2019

IEC 62304:2006/AMD1:2015

IEC 60601-1 Ed. 3.2

IEC 62366-1:2015/AMD1:2020
At CLEIO, our integrated design process follows the highest development standards. From concept to market, all our teams are involved and collaborate to make the product evolve according to the recommendations of our quality assurance experts.

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.

In addition, our teams develop your products according to applicable harmonized standards to meet the medical device’s regulatory requirements. It speeds up the time to market and facilitates product approval by relevant authorities.
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