Medical Device Engineering Firm

CLEIO is a medical device engineering firm providing expertise in mechanical, electronic, embedded software, human factors and system engineering. We support the development of complex medical technologies, from early requirements definition and system architecture to verification, validation, and preparation for manufacturing.

Medical Device Engineering Expertise Built for Regulated Environments

Medical device engineering at CLEIO is adapted to the technical, clinical, and regulatory constraints of each project. Our multidisciplinary teams develop complex medical technologies for healthcare companies, medical device manufacturers, and innovative startups.

Connected Medical Systems

Connected medical technologies that integrate hardware and embedded software, and cloud connectivity for real-time clinical data exchange.

Therapeutic Medical Devices

Therapeutic medical devices that deliver treatment with precision, safety, and clinical consistency.

Diagnostic & Imaging Medical Devices

Diagnostic and imaging devices that enable accurate data acquisition, signal processing, and clinical decision-making.

Drug Delivery & Combination Devices

Drug delivery and combination devices for precise dosing, reliable administration, and regulatory compliance.

Surgical & Interventional Systems

Surgical and interventional systems designed for precision, reliability, and safe performance during clinical procedures.

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End-to-End Medical Device Engineering Process

CLEIO applies a structured medical device engineering process that integrates all technical disciplines across development phases, from early concept definition through production readiness.

System Scope Definition

Our engineers analyze the clinical environment, user workflows, and technical constraints to define the system scope and establish design parameters for the medical device.

System Architecture

Our team translates user needs, performance expectations, and regulatory constraints into detailed engineering requirements and a structured system architecture.

Development and Integration

Our team develops mechanical, electronic, embedded software, and system components in parallel to create integrated and testable product subsystems.

Verification & Validation

We conduct structured testing to verify system performance, safety, and usability, confirming that the medical device meets design requirements and regulatory expectations.

Design Transfer

Our engineers prepare manufacturing documentation, finalize specifications, and coordinate with suppliers to ensure a controlled transition from development to production.

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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

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

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.