Design eye-catching, elegant, and intuitive software screens and workflows with guidance from our experienced and award-winning Industrial Design experts.
Integrate your product with other medical systems using proven communication technologies (e.g. BLE, LTE, WIFI, Zigbee, RFID, RF, MICS), empowering new product indications like remote monitoring or data analytics.
Develop bare metal / RTOS / OS based solutions for a large variety of benchtop, portable, wearable, and implantable devices. Integrate with our Cloud Data Management Platform using Wireless Connectivity to offload key medical data for analytics.
Train and develop ML models or integrate existing proprietary models into complex software systems compliant with the latest regulations.
Full lifecycle management of custom Linux or Windows distributions for your embedded device, including OS updates, patches, OTA update processes, and integration with the manufacturing process.
Build highly performant and scalable medical software targeting a variety of hardware like phones, tablets, PCs, custom hardware, or web browsers (e.g. web apps, mobile apps, surgical planning or navigation systems).
Partner with Vantage MedTech’s embedded and nonembedded software engineers to help you bring exciting innovation to your users.
Medical device software is a component, part, or accessory of a medical device that controls its operations or analyzes data.
This software can be embedded in the device itself or operate separately on a computer or mobile device.
It can be helpful for diagnosing, monitoring, and treating various medical conditions.
SiMD (Software-in-a-Medical-Device) is software that is embedded in a medical device and functions as a component of that device.
On the other hand, SaMD (Software-as-a-Medical Device) is standalone software that performs medical functions without being part of any hardware.
While SiMD relies on a specific device to operate, SaMD can run on general computing platforms and is often more flexible in its applications.
Class I, II, and III medical devices vary in risk levels and regulatory requirements.
Class I devices are low-risk and need basic controls such as labeling. Examples include bandages and tongue depressors.
Class II devices have moderate risk and require additional controls like performance standards, infusion pumps are an example.
Class III devices are high-risk and need pre-market approval. These are often life-supporting devices like pacemakers.
The FDA approves medical device software through a rigorous process that evaluates its safety and effectiveness.
Initially, developers submit a pre-market notification or a pre-market approval application, depending on the device's risk classification.
The FDA reviews the software's design, clinical data, and quality assurance measures.
After successful evaluation, the FDA grants approval, allowing the software to enter the market.
Almost every medical device now runs on software to enhance precision, data analysis, and ease of use. Software allows for real-time monitoring and quick adjustments, which are crucial in medical settings.
Common examples of medical devices that rely on software include infusion pumps, ventilators, and diagnostic imaging systems like MRI and CT scanners.