Innovation Without Borders: 🇺🇸 Why U.S. Teams Still Look to Canada for Product Development 🇨🇦

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.

Our expertise

Human Factors & Design

Human Factors Engineering, User Experience, User Interface & Industrial Design

Engineering

Electronic & Mechanical
Engineering for your Physical Products

Software Development

Software & Firmware Development for Digital Ecosystem

Quality Assurance & Regulatory Compliance

Quality Management, Risk Management, Documentation & Regulatory Compliance

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

Facing roadblocks? Need external support? Our experts will answer your questions, help you navigate challenges, and guide you through every stage of your product development journey.

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.

Get a Free, 45-minute Consultation with our Industry-Leading Experts

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.
PROJECTS

Discover the Innovations
We’ve Brought to Life

From life-saving MedTech innovations to intuitive digital experiences, breakthrough consumer products, and cutting-edge industrial solutions, explore our projects.
TESTIMONIALS

What our partners
say about us

300+ Customers

Let's talk about your project