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

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.

Delivering Results Through Integrated Expertise for 20 Years

Our strength comes from the depth and diversity of our expertise. Over the years, we’ve built a team of experienced professionals from a wide range of industries, each bringing unique skills and perspectives. This collective knowledge allows us to address complex challenges with confidence and deliver results that go beyond expectations.

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

WHAT WE DO

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

We support forward-thinking companies in designing and engineering new advanced technologies for the MedTech and healthcare industries.
From connected devices and diagnostic tools to therapeutic systems and digital health platforms, our team brings the technical depth and regulatory understanding needed to turn complex ideas into high-performing, compliant products.

Digital Health & Monitoring

Therapeutic Devices

Diagnostic & Imaging Tools

Specialized Systems

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.

OUR PROCESS

Our Medical Device Design & Development Process

At CLEIO, every team follows a unified process to design and develop new products. This shared framework keeps phases and deliverables aligned, making collaboration seamless. It fosters clear communication, sparks fresh ideas, and supports collective problem-solving.

1

Immerse

We start by analyzing the problem, user environment, and market landscape to identify real needs and opportunities.

2

Define

We shape the solution by aligning technical requirements, user expectations, and success criteria through collaborative iteration.

3

Elaborate

We start by analyzing the problem, user environment, and market landscape to identify real needs and opportunities.

4

Adapt

We validate the solution through real-world testing, integrating feedback to meet regulatory standards and user needs.

5

Launch

The product moves into production and market release, ready to operate and meet its purpose in the real world.
WHY CLEIO

Why Teams Choose CLEIO

(and Stick Around)

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.
TESTIMONIALS

What Our 300+ Partners Say About Us

4.6 / 5 Stars Customer Satisfaction Rating

Let's talk about your project