Healthcare innovation today hinges on software that not only powers devices but also transforms how care is delivered, enabling smarter diagnostics, seamless connectivity, and intuitive user experiences. Whether developing a wearable health monitor, surgical navigation tool, or AI-driven digital therapy, tailored medical device software is essential to meet clinical needs and regulatory demands.
Vantage MedTech brings over three decades of expertise in developing medical device software, working closely with OEMs to build custom solutions that excel in performance, compliance, and usability. From embedded firmware to standalone applications, we guide every phase from initial concept through validation and commercialization to ensure your software truly enhances patient outcomes and product success.
Medical device software refers to any software that plays a role in the diagnosis, monitoring, or treatment of patients. It may be embedded directly in a device (SiMD) or exist as a standalone application (SaMD). Examples include:
Whether embedded in hardware or cloud-based, medical device software must meet rigorous standards for performance, cybersecurity, and usability.
With Vantage, you’re not just getting a software developer; you’re gaining a cross-disciplinary team of engineers, clinicians, designers, and regulatory experts. We work side-by-side with our clients to translate bold product visions into robust, user-friendly systems that meet both technical and clinical requirements.
Your software should be as intuitive as it is powerful. Our industrial design team collaborates closely with clinical users to build workflows and interfaces that reduce friction, streamline procedures, and improve adoption.
Enable your device to communicate securely with other medical systems and platforms. We implement proven communication protocols like BLE, Wi-Fi, LTE, Zigbee, and MICS, unlocking capabilities such as:
Whether you’re developing a benchtop diagnostic unit, a wearable sensor, or an implantable device, our team builds firmware and embedded OS solutions (bare metal, RTOS, Linux, Windows) optimized for performance and reliability.
We design and deploy standalone software applications that perform medical functions independently of hardware, such as surgical planning systems, mobile diagnostics, or AI-based clinical decision support. Platforms include mobile, web, PC, and custom environments.
We help you develop or deploy AI/ML models into medical systems, always with a focus on regulatory clarity. Applications range from image analysis and predictive algorithms to personalized therapy and triage tools.
From initial configuration to patching and over-the-air (OTA) updates, we manage custom Linux and Windows distributions for your medical device, keeping systems secure, compliant, and current over the full product lifecycle.
Medical device software must meet not just technical demands, but strict regulatory and cybersecurity standards. We embed compliance into every line of code, ensuring your system is:
From documentation to design verification, we help clients reduce risk and accelerate approvals.
Our clients span the full continuum of care, and our medical device software powers products in diverse clinical settings:
At Vantage, we build software that solves complex problems. For one client, we engineered a multi-modal visualization control unit that balanced the technical needs of development teams with the intuitive workflows required by surgeons. In another case, we designed a custom orthopedic mapping platform including firmware, UI, and cloud backend that enabled real-time surgical feedback and was informed by top clinical advisors.
Our role is to reduce complexity while enhancing performance, and these case studies reflect the depth and flexibility we bring to medical software development partnerships.
The pace of change in medical technology is accelerating, and developing medical software that keeps up with regulatory, user, and market expectations is more critical than ever. Whether you’re refining an existing system or envisioning an entirely new solution, Vantage MedTech is your partner for custom medical device software development. We’re here to help you design, build, and launch technologies that improve care, drive adoption, and stand the test of time.
Ready to talk about what’s next?
Medical device software is a component, part, or accessory of a medical device that controls its operation or analyzes its data. It may be embedded directly within the device or operate independently on a computer or mobile platform. By enabling accurate diagnostics, continuous monitoring, and effective treatment, this software plays a vital role in improving patient outcomes and advancing medical care.
SiMD (Software in a Medical Device) refers to software embedded within a medical device that functions as an integral component of that device, while SaMD (Software as a Medical Device) is standalone software that performs medical functions independently of any physical hardware. Unlike SiMD, which depends on a specific device to operate, SaMD can run on general computing platforms, offering greater flexibility and broader applications.
Medical devices are classified by the level of risk they pose and the amount of regulatory control required to ensure safety and effectiveness:
The FDA approves medical device software through a rigorous review process designed to ensure its safety and effectiveness. Developers begin by submitting either a premarket notification (510(k)) or a premarket approval (PMA) application, depending on the device’s risk classification. The FDA then evaluates the software’s design, clinical data, and quality assurance processes. Once the review is successfully completed, the FDA grants approval, allowing the software to be marketed and used in clinical settings.
Nearly all modern medical devices now rely on software to enhance precision, enable data analysis, and improve ease of use. This software allows for real-time monitoring and rapid adjustments—capabilities that are essential in clinical environments. Common examples of medical devices that incorporate software include infusion pumps, ventilators, and diagnostic imaging systems such as MRI and CT scanners.