Medical Device Software

Advance innovation in the exciting and dynamic medical device software market, a segment that has no bounds.

Medical Device Software is Evolving Rapidly

Opportunities are endless in medical device software development. Let’s partner in this advancing segment together.
User Experience/User Interface Design
User Experience/User Interface Design

Design eye-catching, elegant, and intuitive software screens and workflows with guidance from our experienced and award-winning Industrial Design experts.

Wireless Connectivity
Wireless Connectivity

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.

Embedded Software Systems
Embedded Software Systems

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.

Artificial Intelligence
Artificial Intelligence

Train and develop ML models or integrate existing proprietary models into complex software systems compliant with the latest regulations.

Embedded OS Configuration & Support
Embedded OS Configuration & Support

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.

Software as a Medical Device
Software as a Medical Device

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).

Therapeutic Areas

Infectious Disease
Cardiovascular Health
Pain Management

Want your Medical Device Software to Stand out?

Partner with Vantage MedTech’s embedded and nonembedded software engineers to help you bring exciting innovation to your users.

Depth of expertise in specific clinical segments, reinforced by our people, processes, portfolio and proprietary platforms


Frequently Asked Questions

What Is Medical Device Software?

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.


What Is The Difference Between SiMD & SaMD?

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.

What Is The Difference Between Class I, II, and III Medical Devices?

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.

How Does The FDA Approve Medical Device Software?

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.

What Is The Most Commonly Used Medical Device Software?

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.