Software development for medical devices and SaMD
Looking for a trusted partner to elevate your healthcare software? Meet Vention. Backed by 20+ years of expertise, we specialize in simplifying medical device software and SaMD development, blending consulting and engineering expertise to ensure peace of mind at every stage.
The heartbeat of better healthcare
Our mission? To empower you with innovative, efficient, and accessible solutions that truly make a difference for doctors and patients alike.
Medical software we deliver
We build custom solutions — software for medical devices and software as a medical device — designed to deliver a seamless user experience while providing accurate, actionable data at every step of the healthcare journey.
SaMD is revolutionizing healthcare by providing cutting-edge solutions that serve medical purposes while operating on non-medical hardware such as smartphones, tablets, and PCs.
SaMD empowers patients and healthcare specialists with advanced capabilities, including:
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Screening and diagnosis
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Prevention of diseases and complications
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Monitoring and alerting
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Chronic condition and disease management
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Digital therapeutics
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Treatment planning
An integral part of medical hardware, medical device software effectively meets the needs of nurses, surgeons, physicians, lab assistants, and technicians and supports the following critical capabilities:
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Embedded analytics and intelligence
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Monitoring and alerts for anomalies
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Diagnostics
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Medical IoT (internet of things)
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Connectivity of medical devices with hospital systems
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User interaction via intuitive user interfaces
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Safety mechanisms like fail-safes and error detection
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Device management and operation
We're skilled in working with FDA classes I and II of medical devices.
Specific features
Software example
Specific features
Low-risk devices that are unlikely to cause injury
Software example
Device management (for calibration and maintenance scheduling)
Specific features
Moderate risk, supports diagnosis or monitoring
Software example
Device management (for real-time monitoring of medical device performance)
Sleep apnea monitoring app
Our medical device software development services
From medical device manufacturers to healthcare providers, from established enterprises to ambitious startups, Vention partners with organizations facing the complexities of regulatory compliance, seamless system integrations, and the demand for secure, user-friendly software that enhances patient outcomes and streamlines workflows.
Consulting
Rely on Vention for expert guidance at every stage of your medical device software development journey. Whether you’re refining your product concept, defining its use cases, or tackling implementation challenges, our team knows the drill.
With Vention by your side, you’ll deliver a product that’s functional, secure, and a step ahead of the competition.
Custom development
We craft software tailored to your goals, driving growth and delivering patient experiences that work seamlessly and intuitively.
Whether outsourcing entirely, expanding your team’s expertise, building from the ground up, or refining an existing product, Vention brings the precision and reliability needed for the healthcare industry’s toughest challenges.
Medical device software development: the Vention way
From concept to execution, we test, refine, and iterate at every stage of the software engineering process to deliver high-quality solutions quickly.
Our consultants engage in deep, insightful discussions with your stakeholders and conduct thoughtful market research to crystalize three essential pillars of your project:
- Software intended use: Whether it’s monitoring PGHD or analyzing medical images, we help clarify the “why” of your software.
- Target audience: From patients and their families to healthcare providers, caregivers, and fitness enthusiasts, we understand the unique needs of every group.
- Competitor landscape: We analyze existing solutions to identify gaps and opportunities that will set your software apart.
Design
By asking the right questions and uncovering key insights, our consultants define and prioritize functional and nonfunctional requirements and ensure your medical device software is purpose-built to deliver impact.
We also design software architecture blueprints and define the technology stack to meet your performance and scalability needs.
Meanwhile, our designers create intuitive user interfaces that make human-computer interactions seamless and enjoyable, minimizing users' learning curve while maximizing engagement.
Comprehensive documentation is prepared at each stage to streamline both future development and regulatory clearance.
Development
Our developers specialize in crafting software for highly regulated healthcare environments. Whatever component your solution needs — think a cloud platform, a mobile app, or AI algorithms — Vention ensures smooth implementation backed by thorough code reviews, traceability, and adherence to coding standards.
To ensure high software quality and accelerate feature and update deployment, our team builds CI/CD pipelines and makes the most of other essential DevOps practices.
To protect sensitive medical data, our experts implement all the needed security controls, such as secure interoperability protocols and role-based access to medical data.
We also focus on delivering intuitive interfaces designed for quick task completion and reduced cognitive load.
Integration
We integrate hardware medical devices, wearables, and other systems into cohesive IoMT solutions that prioritize real-time insights and user needs.
No matter if it’s developing custom APIs and SDKs for commercial products or integrating with critical systems like EHR, LIS, or insurance platforms, our team ensures seamless functionality. We also guarantee compliance with global interoperability standards, including HL7, FHIR, and DICOM, to support both internal hospital systems and consumer-facing applications.
Testing and quality assurance
Concurrently with development, our quality assurance experts conduct testing to ensure that the software is both high-quality and secure.
Following IEC 62304 and FDA testing requirements, our QA engineers check that medical device software functions as intended, even under load, and smoothly communicates with other systems. We also verify that the design and implementation are in line with the product specification and that the user experience is flawless.
We also test updates and patches to ensure they do not compromise safety or functionality.
Evolution
Our work doesn’t stop at launch. Upon request, we continue to refine your medical device software, updating AI algorithms for improved diagnostics, adding integrations for enhanced interoperability, and deploying security patches to maintain data protection. Together, we ensure your software evolves to meet the changing needs of healthcare.
Let’s build a healthier future together
Partner with Vention and get comprehensive medical device software development services designed to deliver innovation, accuracy, and peace of mind.
Your shortcut to regulatory success
Vention helps ensure your medical device software and SaMD meet all relevant standards and regulations, allowing your company to maintain compliance in a highly regulated industry. Our specialists excel at navigating the complexities of:
ISO 13485
IEC 62304
HIPAA
HITECH
ONC
Hear from our expert
Compliance starts at the software design stage, where the software's intended use and classification are defined. Addressing regulatory requirements from the outset minimizes costly redesigns and accelerates the path to approval.
Comprehensive documentation is equally crucial — from the initial design phase through software development — to ensure alignment with specifications. This thorough documentation serves as the backbone of regulatory submissions, streamlining the approval process when the software is ready..”
Healthcare Engineering Manager
Why Vention is your vital partner in software development for medical devices
Years of experience in software development
Healthcare projects completed for the likes of Thirty Madison and Dialogue
Dedicated healthcare experts
Engineers seasoned in all major healthcare regulations, including HIPAA, HITECH, HITRUST, FDA, GDPR
ISO 27001-certified to safeguard your data through internationally recognized security management practices
Blending reliability and innovation, Vention has multiple recognitions by reputable agencies:
Inc. 5000
Six-time honoree among America’s fastest-growing private companies
IAOP
Four-time honoree on the Global Outsourcing 100 list by the International Association of Outsourcing Professionals
Financial Time
Five-time honoree among the fastest-growing companies in the Americas
We’re also recognized for our achievements in the healthcare industry:
Most Innovative Healthcare Software Development Enterprise 2024
Healthcare AI Engineering Pioneers of the Year 2024
Feel the pulse of cooperating with us
With 20+ years of experience in custom software development, Vention has empowered over 500 of the world’s top companies. Our clients consistently celebrate our dedication to their success and the strength of our partnerships.
CTO of a medical device startup
“We’re researching new medical monitoring indications for patients with specific conditions and risks. We sought an integrated solution that would allow our custom sensors to interface with a variety of preexisting tablet and mobile devices.
From the beginning, Vention approached the project with the right perspective. Their team was interested in engaging in a rapid development cycle, which fit our needs. They were ready to understand and quickly move to the specification and prototype phases.
I was impressed by their ability to understand what was asked and turn the question into functional solutions that accounted for the literal request and potential pitfalls.”
We inject innovation into every line of code
Take advantage of innovative medical technologies to generate insights vital for disease prevention, diagnosis, and treatment.
Transform your approach to diagnosing, treating, and communicating with patients. Our engineers build powerful AI/ML-based software that dramatically improves care delivery.
Make smarter decisions with in-depth patient and clinical data analysis, enabling greater personalization, improved efficiency, and enhanced security.
Leverage immersive worlds and anatomic 3D visualizations for improved decision-making and the quality of care and outcomes.
Generate, collect, analyze, and transmit data via a connected infrastructure of health systems and services and let your patients enjoy high-quality remote care.
FAQ
How much does it cost to develop medical device software?
The cost varies based on the solution you need. For example, creating a mobile medication reminder app will require a different investment compared to developing an AR-powered surgical assistant.
We’d be happy to provide a tailored estimate. Use our development cost calculator for a ballpark figure, or contact us directly to discuss your project in detail.
How long does it take to develop medical device software?
The timeline depends on the complexity of your project. A simple app might take a few months, while more advanced solutions like AR-driven tools can take a year or more.
Once we know your specific needs, we’ll be able to map out a realistic timeline for you.
What technologies would you use?
The short answer: Whatever best suits your business needs. Having expertise in dozens of technologies, we’ll work closely with you to ensure the best fit for your project.
Can I request help with a part of the process, or do you commit to full-cycle services only?
We offer full-cycle medical device software development services, but you’re welcome to request any individual service component you need. From UI to medical device integration or any specific part of the process, we're always happy to support you.