Why is SaMD? Examples of Software as a Medical Device
New technologies have allowed SaMD to gain fast-growing popularity over the last few years. It’s still a relatively new and revolutionary category for the medical device field, with evolving healthcare industry regulations over time and improving the safety of patient information.
According to the International Medical Device Regulators Forum (IMDRF), SaMD is “a software intended to be used for one or more medical purposes that perform these purposes without being part of a hardware medical device.”
Here are the examples of SaMD solutions:
- Applications for viewing images from MRI, Ultrasound, or X-Ray examinations;
- Computer-Aided Detection software for image post-processing for detecting cancer;
- Software using AI for analyzing the test results and detecting pathologies;
- Software that analyzes the data from other devices for assessing the patient’s health state and calculating the risks;
- Applications that calculate the medicine dosage based on the patient’s condition.
The functionality of a SaMD product is highly dependent on its medical purpose and target audience. Here are the different types of the key standard SaMD functionality:
Medical Functionality:
- Screening and medical diagnosis software
- Monitoring and alerting
- Digital treatment
- Medical calculations
- Advanced medical functionality
Data Storage & Compliance Features:
- Cloud data storage
- Security compliance
Management Features:
- In-app guidelines
- Marketing
The Jelvix team offers full-lifecycle medical device software development with professional support at all stages. Let us tell you briefly about the development process in our team:
- Gathering the Requirements
- Creating the Roadmap
- Writing the Specification
- UI\UX Design
- Product Development
- Quality Assurance
- Deployment
- Support & Maintenance
The healthcare field is moving faster than it has in the past, and new applications will be driven by software, and most of that software will be SaMD. Still have questions about Software as a Medical Device? Read our full article here.
