Physical Medical Devices & Equipment Development

End-to-end development services for regulated medical hardware and clinical equipment. CLEIO supports MedTech teams in building robust physical devices that meet regulatory requirements, handle real-world constraints, and perform reliably in clinical environments.

We Develop Medical Hardware Solutions for Every Clinical Application

Medical hardware solutions and clinical equipment take many forms, each with its own technical, clinical, and regulatory requirements. CLEIO designs and develops a wide range of devices, adapting its approach to the specific constraints of each application.

Therapeutic Medical Devices

Hardware designed to deliver energy, mechanical force, or biological stimuli for treatment, rehabilitation, or patient care.

Diagnostic & Imaging Medical Devices

Systems built to collect, process, and display clinical data to support accurate diagnosis and clinical decision-making.

Drug Delivery & Combination Devices

Devices that integrate a physical delivery mechanism with a medicinal product to ensure precise dosing and patient safety.

Surgical & Interventional Devices

Instruments and systems developed for invasive or minimally invasive procedures, requiring precision and reliability in surgical environments.

A Structured Process Built for the Complexity of Medical Device Hardware Design

Medical device hardware design and clinical equipment development require a structured, controlled approach from concept through production. CLEIO follows a clear, step-by-step process to guide development, reduce risk, and ensure every device is ready for approval and manufacturing.

Concept & Architecture

We define user needs, intended use, and system requirements, and establish the overall architecture while identifying regulatory pathways, design constraints, and risks.

Design & Prototyping

We translate requirements into detailed designs across all engineering disciplines and iterate on prototypes to explore form, function, and integration while validating technical and usability assumptions.

Validation & Verification

We confirm that the device meets its design specifications and fulfills actual user needs in its intended clinical environment through testing and evaluations.

Regulatory Documentation

We compile the technical documentation required for market approval aligned with FDA, Health Canada, EU MDR, and applicable standards.

Manufacturing Transition

We transfer the design to production through design for manufacturability reviews, supplier qualification, process validation, and quality controls.

Ready to get started?

The Right Capabilities, Applied at Every Stage of Medical Device Hardware Design

Medical device hardware design and clinical equipment development require that every activity supports performance, reliability, and regulatory compliance while keeping the full system in focus. CLEIO brings together the key capabilities you need to design, test, and prepare devices for manufacturing and market entry.

Component Selection

We identify and evaluate components based on performance, availability, regulatory compliance, and long-term supply chain reliability.

PCB Development

Our electronic engineers design, layout, and iterate on printed circuit boards to ensure signal integrity, power efficiency, and seamless integration within the overall system.

Enclosure Design

We design enclosures that meet clinical environment constraints such as sterility, durability, ergonomics, and manufacturing requirements, while reflecting the intended user experience.

Bench Testing

We build and execute bench test protocols to validate electrical, mechanical, and functional performance at the component and system level.

Supplier Sourcing

We identify, evaluate, and qualify suppliers to ensure component quality, regulatory traceability, and supply chain resilience throughout development and production.

Manufacturing Preparation

Our team prepares design outputs, assembly documentation, and process validation plans to support a controlled and efficient transition to production.
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

Medtech Projects Showcase

Smart Patient Monitoring System with Companion App

We designed and engineered an innovative home-use patient monitoring sensor to track incontinence.

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).
TESTIMONIALS

What Our 300+ Partners Say About Us

4.6 / 5 Stars Customer Satisfaction Rating

Trusted by Industry Leaders

WHY CLEIO

Why Teams Choose CLEIO

(and Stick Around)

Ready to Step Up your Medical Device Development?

Free Access to 1:1 Consultation with Product Experts

Get free direct access to our senior product development experts.

Ready to get started on your project?

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