Outsource Wearables & Medical Device Software Development Services
Creating a healthcare device is complex. We help companies ship FDA-cleared medical device software.
At Pi Tech, we turn medical device concepts into FDA-cleared products. Our senior engineers have navigated 510(k) submissions and Class II & Class III software requirements. Whether you’re developing life-saving equipment, connected wearables, or SaMD solutions, we ship compliant software while others are still writing requirements documents.
Hand us your device concept. We'll help you handle the FDA maze.
Expert Medical Device Software Development For Every Need
Embedded Software for Medical Devices
Your hardware needs more than reliable code. It needs software that survives FDA review. We build embedded systems that control core device functions with precision and stability—even in life-critical environments.
These systems power:
- Infusion pumps with real-time dose control
- High-resolution imaging machines
- Life-supporting ventilators
- Robotic surgical devices
Everything is built with performance and safety at the core, designed to pass the toughest regulatory reviews.
Healthcare Wearable App Development
Connected wearables face unique FDA challenges: continuous monitoring, wireless coexistence, cybersecurity requirements. We've solved them all, from 510(k) to market launch.
We develop end-to-end ecosystems for wearables, including:
- Apps for continuous glucose monitoring
- Cardiac and ECG tracking tools
- Respiratory and sleep monitors
- Remote health monitoring platforms
You get HIPAA-compliant, user-friendly software that works seamlessly with your device and integrates with care workflows.
Software as a Medical Device (SaMD)
SaMD (Software as a Medical Device) represents the fastest-growing FDA submission category—and the most complex regulatory pathway. We've navigated FDA's evolving AI/ML guidance and delivered cleared diagnostic algorithms.
We help you build:
- AI-powered diagnostic platforms
- Digital therapeutics
- Medical imaging tools
- Clinical decision support systems
Our team handles everything from architecture to compliance, ensuring your software meets the standards of a true medical device.
Medical Device Companion Software
Even the most advanced device needs to be usable in the real world. That’s where companion software comes in—connecting patients, providers, and devices in one smooth experience.
We design:
- Dashboards for clinicians to track and manage patient data
- Mobile apps that empower patients
- Remote monitoring systems
- Secure data analytics and visualizations
These tools turn your raw data into actionable insights and help users interact with your technology in meaningful ways.
Why Medical Device Companies Choose Pi Tech
Specless Engineering: A Better Way to Build Medical Device Software
Many companies delay coding until they have a massive, detailed specification. We take a different approach. With Specless Engineering, we start by focusing on your goals, not paperwork. This lets us adapt as your needs change without risking compliance. The result is faster delivery, greater flexibility, and full regulatory compliance.
Senior-Only Talent for Life-Critical Applications
When lives depend on your software, you need experienced engineers, not juniors learning on the job. That’s why Pi Tech hires only senior developers with proven healthcare expertise. Our team builds embedded systems with real-time operating systems, integrates sensors for precise health monitoring, and designs low-power firmware to maximize battery life.
Built-In Regulatory Expertise
Navigating FDA, HIPAA, and other healthcare regulations can slow projects down. We integrate compliance into every phase of development to minimize risk and help accelerate approvals. Our experience means you won’t be blindsided by regulatory surprises, allowing you to focus on innovation.
Security and Privacy First
Protecting patient data is a responsibility. We design every system with robust security controls and privacy safeguards, ensuring your software keeps sensitive information safe from evolving threats and meets strict healthcare standards.
Powering Real-Time Insights During TAVR Procedures
Xenter’s TAVR SmartWire is a breakthrough dual-sensor guidewire designed to improve how data is collected during complex heart procedures.
To realize its full promise, Xenter needed a secure, real-time platform that could stream detailed pressure data, operate seamlessly within hospital wireless networks, integrate with clinical systems, and scale from trials to commercial use, all while meeting stringent FDA and HIPAA requirements.
Our Solution
Pi Tech partnered with Xenter using our Specless Engineering methodology—a flexible, iterative approach focusing on outcomes over rigid documentation. This allowed us to move quickly without sacrificing precision or compliance.
Here’s how we tackled it:
- Developed a real-time data interface to display key metrics such as aortic and left ventricular pressure, giving clinicians fast, actionable insights during the TAVR procedure
- Defined an “AI-ready” architecture, preparing the platform to support predictive analytics and clinical decision support without disrupting existing workflows
- Simulated device behavior with API mocks and test hardware, allowing us to progress quickly even while the backend infrastructure was still evolving
- Engineered for compliance from the start, meeting the data security and process standards needed for FDA 510(k) submissions
Technologies Used
Frontend: React Native (iOS & Android), React (Web)
Want to learn how Pi Tech can support your next digital health innovation?
Our Medical Device Software Development Process
1. Strategic Discovery
We align with your clinical goals, regulatory pathway, and technical realities.
From intended use to integration challenges, we work closely with your team to define success in the clinic and with regulators.
2. Architecture & Design
With a clear vision, we design a system that’s built to perform and built to comply.
Our team creates a software architecture that supports real-time performance, scales for future features, and accounts for user needs and regulatory requirements.
3. Agile Development
We don’t wait months to show progress.
Our iterative approach delivers tested, working software in short sprints—complete with weekly demos, feedback loops, and the flexibility to adapt as your needs evolve.
4.Comprehensive Testing
We apply rigorous quality checks throughout development, including unit tests, integration tests, and real-world user acceptance testing using clinical scenarios.
Our Custom UI/UX Design Services
We design digital healthcare experiences that are easy to use, easy to scale, and built with both compliance and care in mind. Whether you're starting fresh or fixing what’s broken, here’s how we can help:
Healthcare Application Redesign
If your current app is difficult to use or slows people down, we’ll help you fix it. We redesign existing tools to feel more intuitive and work better for the people who use them every day.
New Product User Experience
Starting from scratch? We’ll help you design a clean, user-friendly experience from the ground up — from early concepts to a polished launch.
Usability Evaluation
If your current software feels off, we’ll find out why. Through expert reviews and testing with real users, we’ll identify what’s not working and show you how to fix it.
Design Systems Development
We create design systems that make your product feel consistent and make life easier for your design and dev teams as you grow.
Accessibility Compliance
We’ll help you meet accessibility standards like WCAG while still keeping the interface simple and usable for clinical settings.
What Our Clients Say
“In my 20 years of working at technology companies such as Amazon, Groupon, Opendoor, and Jawbone, if I had to pick one person to solve a complicated technology challenge in the shortest time possible, Michael [CTO @ Pi Tech] would be at the top of my list. He is resourceful, scrappy, and has focus, unlike anyone I have ever seen.”
Jason Child
CFO, Arm - Former CFO, Splunk, OpenDoor, Groupon
“In my 20 years of working at technology companies such as Amazon, Groupon, Opendoor, and Jawbone, if I had to pick one person to solve a complicated technology challenge in the shortest time possible, Michael [CTO @ Pi Tech] would be at the top of my list. He is resourceful, scrappy, and has focus, unlike anyone I have ever seen.”
Jason Child
CFO, Arm - Former CFO, Splunk, OpenDoor, Groupon
"We’re impressed with their ability to exceed our expectations and go beyond the scope of the project. In addition, they’re very flexible and highly capable of delivering quality work."
David Hose
COO, Blockware Solutions
"Working with Pi Tech was very easy. They streamlined and managed their engineering time to avoid a large bill, and I was pleasantly surprised with their delivery."
Pat Downing
CTO, Action Title Research
"Michael [Pi Tech CTO] relishes tackling and solving the toughest technical problems. He has the ability to almost intuitively find the core of a solution to a difficult problem, but understands and practices the principle that the core idea to solving a difficult problem is often the first step in a long process to achieve a fully workable solution. He has an extraordinary work ethic, and focuses until the job is completely done."
Ross Bott
President & CEO, SEVEN Networks
"For anyone who is looking to get the job done, Michael [Pi Tech CTO] has never let me down. He’s a 24/7 soldier, from experimentation to design to hard-crafted one-offs. Michael is a jack-of-all-trades in addition to being a great manager and leader. You would be lucky to have his hands and mind in translating your vision into a tangible device or solution."
Steven Goldstein
CEO, MYTI.ai
Ready to Accelerate Your Medical Device Innovation?
Bringing a medical device to market is complex, but with the right software partner, it doesn’t have to be slow or risky.
At Pi Tech, we combine deep healthcare expertise, senior engineering talent, and regulatory knowledge to help you move faster, without compromising safety, security, or compliance.
Contact us to explore how we can support your device, speed up development, and confidently meet every regulatory milestone.
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