Software as a Medical Device (SaMD)

Medical & Digital Health 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 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 Process for Successful Medical Software Development

Our teams contribute to the development of a wide range of medical products: digital health systems, patient monitoring systems, as well as oncology, cardiovascular, and respiratory devices.

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Identify your product’s key features and positioning
Get a cost-effective proof of concept to attract potential investors
Collaborate with a whole team of experts, including strategists, designers, and developers
Have a complete and transparent vision of the project's progress with our IDEAL methodology
Clear up any doubts about project documentation requirements for medical devices and software
Comply with the FDA, Health Canada, and CE certification regulatory requirements

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Medical & Digital Health Software Development

We help you create compliant, market-ready medical software

Mobile healthcare App

Software as a Medical Device (SaMD)

Real-time telemedicine and At Home Health applications

Patient Portals and SaaS

Firmware for Medical Devices

Internet of Medical Things (IoMT)

We are ISO 13485:2016 certified for medical device development

Our Process for Successful Medical Software Development

Want Your Innovative Ideas to Create a Positive Impact?

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