What CLEIO does

CLEIO is a privately held product design and engineering services firm headquartered in Trois-Rivières, Quebec, Canada, founded in 2004. The company delivers end-to-end development of regulated medical devices and digital health products, alongside selected work in industrial, consumer, cleantech, transport, and safety/security verticals, serving medical device manufacturers, digital health startups, and other regulated product developers across North America. Its core offering spans five integrated service lines—Medical Device Development, New Product Development, Product Enhancement & Program Acceleration, Quality/Risk/Regulatory Management, and Manufacturing Support—delivered through eight in-house expertise areas (Human Factors, UX/UI, Industrial Design, Mechanical, Electronic, Software, Embedded Software, and Quality Assurance), governed by an ISO 13485:2016-certified quality management system and aligned to FDA, Health Canada, and EU MDR requirements.

The technology backbone combines a multidisciplinary in-house engineering team with the proprietary IDEAL development framework (Immerse, Define, Elaborate, Adapt, Launch), which embeds design controls, risk management, and documentation traceability across the program lifecycle. Notable technical components include IEC 62304-compliant medical software development, IEC 62366-1 human factors integration, ISO 14971 risk management, IEC 60601-1 electrical safety processes, embedded C/C++ firmware with RTOS and OTA capabilities, and connected IoMT ecosystems with cybersecurity protocols. CLEIO has shipped award-recognized products including the Starpax Polartrak oncology device, the SoundBite Medical calcified artery console (Platinum, Grands Prix du Design 2024), the DragonVision AI-driven ophthalmology diagnostic, the FreeO2 oxygen therapy device, and the Dermadry iontophoresis system.

CLEIO operates a professional services, project-based revenue model with quote-based pricing and no public rates; a free 45-minute consultation serves as the primary entry point, after which engagements are scoped as multi-disciplinary development contracts. Go-to-market is enterprise field sales targeting engineering and product development leaders, supported by content marketing (100+ articles, ebooks, newsletters), active social channels (LinkedIn, Facebook, Instagram), industry conference presence (LSI 2026, Centech Demo Day), and a new Centech Expert Partnership (April 2026) for startup pipeline access. With 50–60+ specialists and 300+ customers served at a 4.6/5 satisfaction rating, the firm is mid-sized and privately owned with no disclosed external investors, and is in an explicit 2025–2026 capacity and US-market expansion phase.

Name

CLEIO

Legal name

CLEIO

Website

https://cleio.com

Company type

Private

Founded year

2004

Operating status

Operating

Headcount range

51–100 employees

Short description

CLEIO is a privately held Canadian product design and engineering firm that delivers end-to-end, ISO 13485-certified development of regulated medical devices, digital health, and connected products for medtech manufacturers, digital health startups, and other regulated product developers across North America.

Ownership category

akta.pro rank

Headquarters

HQ city

Trois-rivières

HQ country

Canada

HQ region

North America

Offices1 record

Markets served

GTM type

B2B

Offering type

Services

Cost components

Personnel, Technology or R&D, Operations, Marketing or Sales, Infrastructure

Revenue model

1. Medical Device Development Services: End-to-end product development services from concept to regulatory submission, provided as professional services engagements. Revenue generated through project-based consulting and development contracts for medical device and digital health companies requiring ISO 13485-compliant development support.
2. New Product Development Services: Full-cycle new product development across industries including industrial equipment, consumer electronics, and connected products. Revenue from structured project engagements with milestone-based delivery and professional services billing.
3. Quality, Risk & Regulatory Management: Structured quality, risk, and regulatory processes built into development from day one. Services include documentation management, regulatory strategy support, and compliance consulting integrated into product development engagements.
4. Product Enhancement & Program Acceleration: Targeted expertise to improve existing products, resolve blockers, and get stalled programs back on track. Revenue from consulting engagements focused on gap assessment, design refinement, and program management services.

Pricing tiers

Go-to-market motion2 records

Distribution channels2 records

Marketing channels8 records

Core offering

CLEIO is an all-in-one product design and engineering firm that provides end-to-end development services for medical devices, digital health products, and other regulated connected products. The company delivers integrated capabilities spanning human factors engineering, industrial design, mechanical, electronic and software engineering, and quality assurance under a single ISO 13485-certified quality management system, taking products from concept through regulatory submission and manufacturing transfer.

Product overview

CLEIO is an all-in-one product design and engineering firm offering integrated product development services across medical devices, digital health, and general product development. The core service portfolio includes Medical Device Development, New Product Development, Product Enhancement & Program Acceleration, Quality, Risk & Regulatory Management, and Manufacturing Support. These services are delivered through integrated expertise areas including Human Factors Engineering, UX/UI Design, Industrial Design, Mechanical Engineering, Electronic Engineering, Software Development, Embedded Software Development, and Quality Assurance. The company operates as a unified ISO 13485-certified team combining strategy, human factors, design, and engineering expertise to bring innovative products from concept to market across regulated medtech, digital health, industrial, and consumer sectors.

Differentiator

Problem solved

Functional benefit

Products and services

• Medical Device Development Integrated medical device development service from concept to regulatory submission under one ISO 13485-certified team. Covers therapeutic segments including cardiovascular diseases, oncology, respiratory, drug delivery, neurology, diagnostics, women's health, and vision care, targeting medical device manufacturers and digital health innovators.
• New Product Development Full-cycle new product development across industries including industrial equipment, consumer electronics, Medtech, consumer tech, industrial and manufacturing, clean tech, transports, and safety and security, delivered as structured project engagements with milestone-based delivery.
• Product Enhancement & Program Acceleration Targeted expertise service to improve existing products, resolve blockers, and get stalled programs back on track. Covers gap assessment, design refinement, manufacturing preparation, change management, and risk management.
• Quality, Risk & Regulatory Management Structured quality, risk, and regulatory processes built into development from day one. Includes design controls, risk management, documentation management, regulatory strategy, and compliance for US, Canada, and EU markets.
• Manufacturing Support Bridging the gap between design and production with manufacturing-ready documentation and supplier coordination, including supplier sourcing, design for manufacturing, cost estimation, and contract manufacturing transfer.

Quantifiable outcome

• 4.6 / 5 Stars Customer Satisfaction Rating
• +2 more outcomes

Named customers10 records

Segments6 records

Ideal customer profiles3 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

AI capability2 records

Feature8 records

Partnerships

One partnership is on record.

• CentechcoreStrategic or Co-development Partner · 1 April 2026CLEIO became an Expert Partner of Centech accelerator program in April 2026. The partnership provides mentorship, expertise, and product development support to startups within the Centech ecosystem. CLEIO experts contribute to Demo Day events and provide guidance to emerging technology companies developing innovative products.

Scale indicators6 records

Recent moves7 records

Expansion highlights6 records

Direct peers

• Veranex (formerly Ximedica): Global medtech design and development services company combining product development, engineering, regulatory, and clinical expertise. Competes head-to-head for ISO 13485 end-to-end medtech programs.
• StarFish Medical: Canadian ISO 13485-certified medical device design, development, and contract manufacturing firm. Like CLEIO, it offers end-to-end development for medtech innovators and operates in the same regulatory and competitive space.
• Synapse Product Development: US product design and engineering consultancy with deep medical device experience. Targets similar medtech startups and enterprise clients needing concept-to-manufacturing support.
• Farm Design: Industrial design and product development firm with significant medical device focus. Comparable in human-centered design, mechanical/electronic engineering, and award-winning industrial design for regulated products.
• Worrell: US-based medical device product design and development firm with human factors and regulatory expertise. Comparable in offering integrated design-to-submission services for regulated medtech clients.
• Key Tech: Medical device product development firm focused on regulated design, engineering, and usability. Comparable in delivering FDA/EU MDR-ready programs for startup and enterprise medtech clients.
• HS Design: Medical and life sciences product development firm specializing in human factors, usability, and regulated device design. Closely comparable capability stack to CLEIO.

Broad incumbents

• Nytec: Full-service product design, engineering, and connected IoT firm with regulated-industry capabilities. Comparable in delivering end-to-end connected medical devices including embedded and cloud software.
• Smart Design: Global product design consultancy with medtech, consumer, and industrial practices. Overlaps in UX, industrial design, and human factors for regulated medical products, though its portfolio is broader and less medtech-specialized than CLEIO's.
• Bresslergroup: Established US product design and engineering firm spanning medtech, consumer, and industrial. Overlaps in industrial design, human factors, and mechanical engineering for regulated devices, but with a broader vertical mix than CLEIO.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat5 records

Key risks7 records

Key highlights7 records

Customer concentration

• Facebookfacebook.com/hellocleio
• LinkedInlinkedin.com/company/hellocleio
• Instagraminstagram.com/wearecleio

Compliance10 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles2 records

Funding overview

Funding rounds

Investors

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about CLEIO