Embedded Software Development for Healthcare Companies
Your medical device needs software that works when lives depend on it. Pi Tech builds embedded systems that pass FDA audits while actually shipping on time.
At Pi Tech, We Build Healthcare Embedded Software That Keeps Regulators Happy While You Ship Fast
No hand-holding. No endless spec revisions. Just embedded software that works in the real world and passes audits.
How We Handle Healthcare Embedded Software From Concept to Compliance
Real-Time Operating Systems for Medical Devices
Your pacemaker can't wait for a system reboot. We build RTOS solutions that respond in microseconds, not milliseconds. Task prioritization keeps critical functions running while background processes handle data logging and communication protocols.
• Preemptive scheduling for life-critical applications
• Interrupt handling that never misses a beat
• Memory management optimized for medical device constraints
• Deterministic timing that auditors can verify
Firmware Development for Connected Medical Devices
IoT-enabled devices need firmware that talks to the cloud without compromising patient safety. We write low-level code that manages sensor data, wireless communication, and power consumption while maintaining HIPAA compliance at the hardware level.
• Secure boot processes that prevent tampering
• Over-the-air updates that don't brick devices
• Power optimization for battery-operated implants
• Encryption protocols built into the silicon
Hardware-Software Integration for Diagnostic Equipment
Your imaging system hardware is perfect. The software integration is killing your timeline. We bridge that gap by writing drivers, calibration routines, and control software that makes complex medical hardware perform like it should.
• Custom driver development for proprietary sensors
• Calibration algorithms that maintain accuracy over time
• Control interfaces that technicians actually use
• Data acquisition systems that capture every measurement
Regulatory Documentation and Validation Testing
FDA submissions require traceability from requirements to test results. We document every line of code, every test case, and every design decision so your 510(k) submission doesn't get rejected for missing paperwork.
• Requirements traceability matrices that make sense
• Automated testing frameworks for continuous validation
• Design controls documentation that satisfies auditors
• Risk analysis and mitigation plans for every component
Pi Tech Advantage for Healthcare Embedded Software Development
Specless Engineering Approach
We start building while others argue about specifications. Weekly demos show real progress on real hardware, so you catch integration issues early instead of during final testing.
Senior-Only Embedded Engineers
No junior developers learning on your dime. Every Pi Tech engineer has built embedded systems that shipped to customers and passed regulatory review.
Healthcare Regulatory Knowledge
We speak FDA. Our embedded software comes with the documentation, testing, and traceability you need for medical device submissions without the usual back-and-forth.
Security Built Into Hardware
PHI protection starts at the chip level. We implement hardware security modules, secure enclaves, and encrypted communication protocols that keep patient data safe even if software gets compromised.
Case Study: Building Real-Time Embedded Software for Life-Critical Heart Procedures
Xenter's dual-sensor TAVR SmartWire needed embedded software that could capture and transmit cardiac pressure data during heart valve procedures. Every millisecond mattered. One delayed reading could impact surgical decisions.
Traditional embedded approaches couldn't handle the real-time requirements while maintaining the wireless reliability needed in operating rooms. FDA compliance added another layer of complexity.
Our Solution
Pi Tech developed embedded software that operates at the intersection of precision and reliability.
- Built real-time data capture systems processing aortic and ventricular pressure readings with sub-millisecond accuracy during TAVR procedures
- Implemented wireless data transmission protocols that maintain stable connections in hospital environments filled with interference
- Created hardware simulation modules for rapid development and testing while the physical SmartWire evolved
Our embedded software bridges the gap between sensor hardware and clinical decision-making. Pressure data streams seamlessly from the guidewire to surgical displays, giving cardiologists instant insights when they need them most.
The platform handles continuous data streams throughout multi-hour procedures without dropouts. FDA requirements for medical device software? Built into every line of embedded code.
Technologies: Real-time embedded systems, wireless protocol implementation, hardware abstraction layers, FDA-compliant firmware architecture, medical device communication standards.
When to Outsource Embedded Software Development
Your Embedded Team Is Drowning in FDA Requirements
Writing firmware is hard. Writing firmware that satisfies FDA auditors while maintaining real-time performance is harder. You need engineers who've done both successfully.
Hardware Integration Keeps Breaking Your Timeline
Every sensor needs custom drivers. Every communication protocol needs debugging. Every power optimization creates new bugs. Pi Tech handles integration so your hardware actually works.
Your Device Needs Security But Your Team Builds Features
Medical devices are hacker targets. Patient data lives on your hardware. Security can't be an afterthought bolted onto existing firmware - it needs to be built into every component
Regulatory Documentation Is Eating Your Development Budget
FDA wants traceability. Auditors want documentation. Your embedded team wants to write code. We handle the paperwork so your engineers can focus on making things work.
Our Embedded Software Development Services
Pi Tech delivers embedded solutions that work in the real world, not just on the bench.
Custom Embedded Software Development
We write firmware optimized for your specific hardware platform. Real-time constraints, power budgets, and memory limitations become design features, not obstacles to work around.
Medical Device Firmware and Drivers
Low-level code that makes your medical hardware perform reliably. Sensor interfaces, communication protocols, and control algorithms that pass validation testing on the first try.
IoT Integration for Connected Healthcare Devices
Secure wireless connectivity that doesn't drain batteries or compromise patient data. Cloud integration that works in hospitals, homes, and everywhere patients actually use devices.
Embedded Security Implementation
Hardware-based security that protects patient data even when software gets compromised. Secure boot, encrypted storage, and tamper detection built into your device architecture.
Regulatory Compliance and Documentation
FDA-ready documentation that traces every requirement to implementation and testing. Design controls, risk analysis, and validation protocols that satisfy auditors without killing your timeline.
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
"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
Ready to Build Embedded Software That Actually Ships?
Your medical device deserves embedded software that works when lives depend on it. No endless revisions, no missed deadlines, no FDA rejections because someone forgot to document a requirement.
Pi Tech builds embedded systems that pass audits and ship on time.
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