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.
Planning Software
Planning Software

Procedural planning software helps the user pair imaging with therapy planning to reduce operating time and improve patient outcomes.


Our expertise can help you introduce procedural accuracy where visibility is a challenge, by integrating navigated tools and imaging during therapy delivery.

Virtual Reality
Virtual Reality

Your device and procedure can be built into a Medical VR experience that takes your users to the next level in education and practice.

Artificial Intelligence
Artificial Intelligence

From data management to procedural assistance, AI has a lot to offer in the medical device space that is disruptive and exciting and will continue to advance how patients are treated.

App and Web Based Medical Software
App and Web Based Medical Software

Access our team of medical device software developers, who bring extensive experience in crafting apps and web products compatible with all major mobile operating systems.


Ensure your device is safe from detrimental device vulnerabilities. We’re more connected than ever and our experts can help minimize evolving risks.

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?

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.