Medical Device Design Services

CLEIO’s medical device design services integrate a human-centered approach into every stage of development. By immersing our team in clinical environments and building a deep understanding of the people who use these devices every day, we create solutions that are intuitive, safe by design, and grounded in real-world needs.

Medical Device Design Services for Every Device Category and Technology

Our multidisciplinary teams deliver medical device design services across all product categories, ensuring usability, safety, and regulatory compliance at every stage.

Connected Medical Systems

Connected medical systems that integrate hardware, embedded software, and user interactions for safe and intuitive use.

Medical Device Software

Softwares that support clarity, usability, and reliable performance in clinical and at-home settings.

Therapeutic Medical Devices

Therapeutic systems that enable safe, consistent, and controlled treatment delivery for both clinicians and patients.

Diagnostic & Imaging Medical Devices

Diagnostic technologies that support accurate data interpretation and confident clinical decision-making.

Drug Delivery & Combination Devices

Solutions that ensure precise dosing, safe handling, and intuitive interaction between the user, device, and drug.

Surgical & Interventional Systems

Devices that support precision, reliability, and ease of use in high-pressure clinical environments.

What Our Medical Device Design Services Cover

Medical device design requires a deep understanding of how real people interact with a device under pressure, in complex environments, with lives on the line. CLEIO offers a full range of human factors and usability services to help you build that understanding, manage use-related risk, and meet regulatory requirements at every stage of development.

User Research & Field Study

We gather insights into user needs, behaviors, and clinical environments through observations, interviews, and field studies.

Use Scenario & Task Analysis

Our team defines use scenarios and breaks down critical tasks to understand the steps users take to achieve their goals within real workflows.

Use-Related Risk Management

We identify and mitigate potential use errors by analyzing user interactions and their impact on safety.

Usability Testing

Our team evaluates designs with representative users to assess usability, identify issues, and guide iterative improvements throughout the development process.

Human Factors Engineering

We apply structured human factors methods to ensure safe, effective, and intuitive use in compliance with regulatory standards such as IEC 62366-1.

User Interface & Industrial Design

Our team creates intuitive UI and industrial design solutions that improve usability, support efficient interaction, and reduce use error risks.
CERTIFICATIONS

Quality Management and Regulatory Alignment Across Medical Device Hardware Design

CLEIO applies an integrated quality management system built on internationally recognized medical device standards, ensuring multidisciplinary development activities follow quality assurance best practices.
ISO 13485 certification ensures that all development work is guided by audited, structured processes that support consistent service quality and reliable outcomes. In parallel, products are developed in accordance with applicable harmonized standards to meet medical device regulatory requirements, accelerating time to market and supporting approval by relevant authorities.

ISO 13485:2016

Quality Management System

ISO 14971:2019

IEC 62304:2006 / AMD1:2015

IEC 60601-1 Ed. 3.2

IEC 62366-1:2015 / AMD1:2020

PROJECTS

Medical Device Design Showcase

Explore medical innovations we’ve worked on.

Revolutionary Oncology Medical Device to Treat Cancer

Our largest project yet. We designed and engineered the Polartrak, a proprietary and revolutionary medical device developed by Starpax Biopharma to treat cancer.

Console for Calcified Artery Disease Treatment

We have collaborated with Soundbite Medical to design and develop the latest commercial version of their medical device.

Ophthalmology Device with Software Driven by AI

Development of an ophthalmology diagnostic tool using offline image analysis software driven by artificial intelligence (AI).

Smart Patient Monitoring System with Companion App

Design and engineering of an innovative home-use patient monitoring sensor to track incontinence.

WHY CLEIO

Why Teams Choose CLEIO

(and Stick Around)

TESTIMONIALS

What Our 300+ Partners Say About Us

4.6 / 5 Stars Customer Satisfaction Rating

Let's Talk About Your Medical Device Project

Free Access to 1:1 Consultation with Product Experts

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Ready to get started on your project?

Our team is ready to help you think, design and engineer it.