Software as a Medical Device (SaMD)

Medical & Healthcare Software Development

We partner with forward-thinking teams to design and develop medical and digital health software that’s intuitive, compliant, and ready for real-world impact. Backed by our certified quality systems and a multidisciplinary team, we accelerate your path to market without compromising safety or performance.

We help you create compliant, market-ready medical software

Medical and Digital Health Software are rapidly transforming the healthcare landscape, as seen in the surge of innovative health applications and connected solutions.

At CLEIO, our strategy, design, and development teams are here to guide you through every step of medical software development. From home health platforms and mobile apps to firmware and IoMT solutions, we deliver secure, user-centered products that meet strict regulatory and cybersecurity standards—ensuring both compliance and real-world impact.

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Mobile healthcare App

Convert existing healthcare services or create new services for a mobile environment. From telehealth to tracking, CLEIO is here to help.

Software as a Medical Device (SaMD)

Get support for the development of FDA-approved Software as a Medical Device (SaMD).

Real-time telemedicine and At Home Health applications

Develop your own platform that enables virtual care on the web or mobile

Patient Portals and SaaS

Create self-service functionality within your practice, allowing patients to self-register, update, do billing, track health, or perform various other tasks.

Firmware for Medical Devices

Build the firmware that powers FDA-approved medical services.

Internet of Medical Things (IoMT)

Design connected wearables or devices for remote patient monitoring, care management, and more.

We are ISO 13485:2016 certified for Medical Device & Software Development

Through co-creation with CLEIO’s experts, your idea is in good hands. You are sure to get reliable software.

Working with our Quality Assurance team, we confirm that the standards’ requirements are met and we create the documentation that accompanies the project. It ensures that our work is fully compliant with the high expectations of the FDA and other health regulatory organizations.

ISO 13485:2016

ISO 14971:2019

IEC 62304:2006/AMD1:2015

IEC 60601-1 Ed. 3.2

IEC 62366-1:2015/AMD1:2020

Our full-stack software engineers develops powerful, interactive, and connected applications

Innovation Strategy

Human Factors Engineering

UX & UI Design

Software Architecture

Technology & Stack Selection

User Interface Integration

System Integration

Front-end Development

Back-end Development

Web, Desktop & Mobile Apps

Risk Management

DevOps & App Deployment

Maintenance & Support

Project Management

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PROJECTS

Discover the Innovations
We’ve Brought to Life

From life-saving MedTech innovations to intuitive digital experiences, breakthrough consumer products, and cutting-edge industrial solutions, explore our projects.

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NEW

Revolutionary Oncology Device to Treat Cancer

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Medical Software for Cognitive Decline

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Medical Device for Oxygen Therapy

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Console for Calcified Artery Disease Treatment

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Osmolarity Test Device for Dry Eyes

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Ophthalmology Device with Software Driven by AI

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Veterinary Anesthesia Ventilator

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Want Your Innovative Ideas to Create a Positive Impact?

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Medical & Healthcare Software Development