Following a year of continued investment in infrastructure, service maturity, and long-term execution, CLEIO, an ISO 13485-certified product development and engineering firm, recently announced the expansion of its integrated product development capabilities for regulated medtech and digital health markets across the United States and Canada.
Throughout 2025 and early 2026, CLEIO further enhanced its internal systems, cross-functional integration, and delivery model to support increased complexity, parallel programs, and long-term client partnerships. These investments build on an already strong foundation and position the firm to scale its services and enter a new growth phase, expanding its ability to support regulated healthcare innovators developing medical devices and software-enabled, connected, and compliant products.
As part of this expansion, CLEIO has been growing its team, with multiple new positions opening across program management and technical disciplines to support increased demand and long-term growth.
This expansion reflects a deliberate evolution rather than a shift in direction. CLEIO’s focus remains on regulated markets, supported by more than 20 years of experience guiding products from early concept through manufacturing. Its integrated approach brings strategy, human factors, design, engineering, software, and quality under one roof to reduce development risks, save costs and accelerate time to market.
As medtech and digital health products increasingly combine hardware, embedded software, cloud platforms, and data-driven intelligence, development teams face growing challenges related to system integration, usability, cybersecurity, and compliance. CLEIO’s expanded capabilities directly address these challenges by aligning human-centered design, technical execution, and regulatory readiness from the earliest stages of development.
“Regulated healthcare companies are under increasing pressure to move faster while maintaining the highest standards of safety, usability, and compliance,” said Laurent Messier, VP of Marketing. “Our investments over the past years have strengthened how we deliver. This allows us to scale that delivery model and support more ambitious, complex programs with confidence and consistency.”
Capabilities include:
- End-to-end development of digital health and medical software, including cloud-connected platforms and IoT architectures
- Embedded software, electronics, and system engineering for regulated medical and connected devices
- Human Factors Engineering and usability validation aligned with FDA, IEC, and Health Canada requirements
- Integrated quality assurance, risk management, and design controls under ISO 13485
- Cybersecurity-aware system design for connected and data-driven healthcare products
- Manufacturing support, sourcing, and design for manufacturability and assembly (DFM/DFA)
CLEIO supports a wide range of therapeutic and application areas, including cardiovascular, respiratory, oncology, neurology, orthopedic, and diagnostic devices, as well as connected wearables and healthcare IoT solutions. The firm works closely with client teams to integrate seamlessly into existing R&D operations or to serve as an extension of internal teams when additional capacity or specialized expertise is required.
Based primarily in Canada while serving both U.S. and Canadian markets, CLEIO offers competitive cost structures without compromising regulatory rigor or technical depth. The firm’s certifications, internal processes, and delivery practices are aligned with FDA and Health Canada expectations, supporting efficient regulatory submissions, audits, and market readiness.
CLEIO is a leading medical device development firm gathering over 60 experts divided into several locations in North America. Over the years, CLEIO has been involved in more than 2,500 projects with a single desire: shaping our future by designing innovative medical devices.
At CLEIO, our mission is clear: we empower visionary minds to shape the future. By seamlessly blending strategy, design, and engineering expertise, we offer an integrated, ISO 13485-certified approach to developing groundbreaking medical devices and cutting-edge technology products. Since 2005, we've partnered closely with ambitious teams—from defining bold new ideas through to production, transforming their visions into realities that improve lives and industries.
Whether supporting high-potential startups eager to bring revolutionary innovations to market, or collaborating with established companies seeking fresh avenues for growth, we're dedicated to fueling progress, fostering innovation, and helping our partners create a meaningful, lasting impact on the world.
