Outsource Healthcare Compliance Software Solutions
Compliance shouldn’t kill your product roadmap. We build software that makes regulators happy while you actually ship. Stop choosing between FDA approval and your launch date.
You know the story. Your team’s ready to ship, but compliance is slowing everything down. The FDA wants documentation. HIPAA needs security policies. Your investors want results.
How We Build Compliant Healthcare Software
Regulatory Risk Assessment
We audit your stack for HIPAA & FDA gaps. No fluff, no 200-page reports. Just what needs fixing to pass your next audit.
- Map your data flows against HIPAA requirements
- Identify gaps in your security controls
- Flag missing documentation before auditors do
- Create a roadmap that actually makes sense
FDA & Quality Management Systems
Class II device? SaMD? We speak FDA. We've done this dance before and know exactly what they want to see.
- Design controls that don't make your developers quit
- Risk management that's actually manageable
- Validation protocols that work the first time
- 510(k) documentation that passes review
Security Architecture & Implementation
Your PHI stays encrypted. Period. We build security that works, not just looks good on paper.
- End-to-end encryption that doctors can actually use
- Access controls that match real clinical workflows
- Audit trails that make sense to humans
- Security monitoring that catches real threats
Ongoing Compliance Management
Compliance isn't a one-time thing. We keep you legal while you iterate.
- Automated compliance monitoring
- Regular security assessments
- Documentation updates as you ship features
- Support when auditors come knocking
Why Healthcare Teams Outsource Compliance to Us
Senior-Only Talent
We only hire people who've been through FDA submissions and HIPAA audits. No learning on your dime.
Specless Engineering Integration
Our designers and developers work with compliance from day one. No nasty surprises during validation.
Mission-Critical Understanding
We know the difference between "nice to have" and "shut down your company." We focus on what matters.
Speed Without Shortcuts
Fast doesn't mean sloppy. We ship compliant code quickly because we've done it before.
Building FDA-Ready Software for Xenter
Xenter was developing a dual-sensor guidewire for heart procedures, a Class II medical device that needed real-time data capture, AI readiness, and bulletproof compliance. They had the hardware. They needed software that wouldn't get rejected by the FDA.
To bring the SmartWire to life, Xenter needed a digital platform capable of wirelessly transmitting high-resolution pressure data to clinicians during live TAVR procedures without lag or disruption. This platform had to operate smoothly within a wireless hospital ecosystem, ensuring interoperability with EHR systems and existing clinical tools.
Our Solution
We built them a platform that captured real-time pressure data during procedures while maintaining full FDA compliance:
- Real-time data interface for aortic and ventricular pressure monitoring
- HIPAA-compliant architecture with role-based access
- AI-ready platform for predictive analytics
The platform passed all regulatory requirements without sacrificing the speed Xenter needed for their clinical trials.
FDA happy. Xenter shipping. Both at the same time.
Technologies used: React Native, React, HIPAA-compliant cloud infrastructure
When to Outsource Healthcare Compliance Software
Your Investors Want Progress. The FDA Wants Perfection
You're burning runway on compliance documentation while competitors ship features. We handle the regulatory maze while you build what matters.
Your Last Audit Didn't Go Well
Gaps were flagged. The clock’s ticking. Your team isn’t sure where to begin. We’ve stepped into worse situations and delivered fixes that pass. Fast.
You’re Launching a Medical Device
Your engineers want to code, not write validation protocols. We handle the 510(k) paperwork while they build the product.
You Had a HIPAA Scare
You got hit with a breach notification. Now you realize “secure enough” isn’t. We rebuild your platform with privacy-first architecture that actually protects patient data and passes scrutiny.
Our Healthcare Compliance Software Services
We don’t just advise on compliance. We build it into the product from day one. Every line of code. Every workflow. Here’s what we deliver:
HIPAA Compliance Implementation
From architecture to deployment, we embed HIPAA compliance into the foundation—encryption, audit logs, and access controls included.
FDA Software Validation
We know what reviewers want to see and what slows approvals down. We create comprehensive validation packages following IEC 62304 standards. Every requirement traced, every test documented, every anomaly addressed.
Security & Privacy by Design
Checkbox compliance isn’t enough. We design systems that actually secure patient data while staying intuitive for the clinicians who use them.
Compliance Automation Tools
Manual tracking won’t scale. We build tools that monitor, alert, and log compliance tasks in real time, so nothing falls through the cracks.
Regulatory Consulting & Support
When you need answers fast, we're here. From audit prep to submission support, we speak regulator.
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 Ship Compliant Healthcare Software?
You don’t have to choose between product velocity and regulatory approval. We’ve helped healthcare startups pass HIPAA audits, clear 510(k) reviews, and launch software that makes a real impact.
Let’s build something that ships fast, scales smart, and keeps regulators on your side.
FAQ
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