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Medical Device Design & Engineering

CLEIO specializes in Strategy, Human Factors, Design, and Engineering for Medical Devices. We harness our expertise to transform your innovative ideas into reality.

Our expertise

Innovation Strategy
Human Factors Engineering
User Experience
User Interface Design
Industrial Design
Mechanical Engineering
Electronic Engineering
Embedded Software Development
Software Development
Quality Assurance
Learn more about our expertise

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

Digital Health & Monitoring

  • Digital Health Systems
  • Patient Monitoring Systems
  • Wearable Health Devices
  • Telemedicine Solutions
  • Remote Patient Monitoring (RPM) Devices
  • Connected Medical Devices (IoMT)

Therapeutic Devices

  • Cardiovascular Devices
  • Respiratory Devices
  • Oncology Devices
  • Neurostimulation Devices
  • Orthopedic Devices
  • Surgical Devices & Catheters

Diagnostic & Imaging Tools

  • Diagnostics & Dashboards
  • Medical Imaging Devices
  • Point-of-Care Diagnostics

Specialized Systems

  • In-Vitro Diagnostic Devices
  • Prosthetics
  • Drug Delivery Systems
  • Rehabilitation Devices

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.

Discover just a few of the medical innovations we tackled head-on

Cardiovascular Health
NEW

Console for Calcified Artery Disease Treatment
Respiratory Health

Medical Device for Oxygen Therapy
Pharmaceuticals

Pharmaceutical Device Revolutionizing Workflows
Vision Health

Ophthalmology Device with Software Driven by AI
Health At-Home

Iontophoresis Medical Device for at-home Treatment
Cognitive Health

Medical Software for Cognitive Decline
Lab Research

Modular Neural Imaging Device
Orthopedics

Orthotic Device with Patented Technology
Explore all Projects

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