Go to ScienceSoft Global
- Medical device software technology consulting
- Market entry consulting for SaMD startups
- Compliance consulting (HIPAA and GDPR compliance, FDA submission, CE marking, and more)
- UI/UX design for medical device software and SaMD
- Cloud consulting, incl. the choice of HIPAA-compliant cloud providers
IT Services for Medical Device and SaMD Providers
Since 2005, ScienceSoft has been helping medical device and SaMD providers engineer robust solutions that are ready for FDA clearance and CE marking.
Medical Device Software ScienceSoft Delivers
Software in a medical device (SiMD)
Software that is integral to a medical device and performs functions like processing data or controlling hardware. Requires FDA clearance.
Sample use cases:
- Device control and image viewing software for ultrasound scanners.
- Image processing and visualization software for MRI.
Software accessories for medical devices
Software complementing or enhancing medical devices but not performing a medical function on its own. Requires FDA clearance.
Sample use cases:
- Remote monitoring systems.
- Remote control software for smart therapeutic devices (e.g., insulin pens, smart inhalers).
- Medication adherence monitoring (e.g., via integration with smart pill bottles).
Software as a Medical Device (SaMD)
Software that can diagnose, monitor, or support clinical decisions without a physical medical device. Requires FDA clearance.
Sample use cases:
- AI-powered treatment and patient care planning.
- Medical image analysis (e.g., for stroke type identification, brain tumor localization).
- Direct disease management (e.g., sleep apnea episode identification, sound therapy for tinnitus patients).
Other software around medical devices
Software supporting operational tasks for use cases not related to diagnosing and treatment. Doesn’t require FDA clearance.
Sample use cases:
- Hospital asset monitoring.
- Scheduling patients for device-based procedures.
Services We Offer to Medical Device and SaMD Providers
Consulting
Software product development
Software support and modernization
- Medical device software maintenance and support
- Medical device software evolution and assistance with re-submission to regulators
- API development for integration with other medical software or devices
- Cloud migration services for SaMD companies
Cybersecurity and compliance
- Medical device cybersecurity assessment
- Compliance assessment (for HIPAA, GDPR, PCI DSS, SOC 2, etc.)
- Ongoing compliance management for SaMD and medical device software
- Penetration testing for medical device software and SaMD
Advanced Technologies for Medical Device Software
Medical Device Software We Engineered and Supported
Our Clients Say
bioAffinity Technologies hired ScienceSoft to help in the development of its automated data analysis software for detection of lung cancer using flow cytometry. In addition to the solid technical expertise shown by ScienceSoft, its developers demonstrated a profound understanding of laboratory software specifics and integrations. We would recommend hiring ScienceSoft to anyone looking for a highly productive and solution-driven team.
Working with ScienceSoft was a pleasure from A to Z. Their deep knowledge of the healthcare industry specifics and DICOM standard helped us create the back end of the software for our ultrasound scanner.
Patrick Pakan
Founder and CEO
Thanks to ScienceSoft’s practical healthcare IT expertise, we created a musculoskeletal therapy platform that can be fully customized and reflect the needs of each program member.
During our cooperation, ScienceSoft proved to have vast expertise in Healthcare and Life Science industries related to the development a desktop software connected to laboratory equipment, mobile application and data analytics platform. They bang top quality talents and deep knowledge of IT technologies and approaches in accordance with ISO13485 and IEC62304 standards.
To develop a mobile application that would enhance a line of Bluetooth-enabled devices for newborn and baby care, we opened an app development tender. ScienceSoft's proof-of-concept was convincing enough for us to further the cooperation. During the project flow we were very pleased by the work of ScienceSoft’s business analysts and developers, who demonstrated high level of skills and competence.