Software as a Medical Device (SaMD)

What We Do
Software as a Medical Device (SaMD)

We help you create compliant, market-ready medical software

Software as a Medical Device (SaMD) is booming in the medical device industry. The proof is in the number of health-related software and applications that have emerged recently.

Our strategy, design, and development teams are here to guide you through medical software development. Whether it’s home health, mobile development, firmware, or IoMT (Internet of Medical Things), we can do it all. Throughout the project, we keep your users in mind and ensure that the development process complies with regulatory requirements and cybersecurity standards.

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.

OptinaDX Brain Health Module

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.

We work with IEC 62304

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Our unique 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.

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