HEALTHTECH
ENGINEERING
FDA TO SCALE
FDA-ready health tech innovation at scale. From AI diagnostics to digital therapeutics, we deliver HIPAA-compliant products with clinical validation, regulatory expertise, and real-world impact across 50M+ patients.
Regulatory Expertise
HIPAA & HITECH Compliant
Full PHI protection, audit logging, BAA agreements, and breach notification procedures
CompliantFDA SaMD Expertise
Pre-cert program, 510(k), De Novo submissions, and Class II/III experience
ExpertCE Marking (MDR/IVDR)
European medical device certification, notified body, and MDR transition
CertifiedISO 13485 & 27001
Quality management for medical devices and information security
CertifiedSOC 2 Type II
Service organization controls for security and availability
Type IIHL7 FHIR R4
Full FHIR R4 implementation with CDS Hooks, SMART on FHIR, and Bulk Data
CertifiedIndustry Challenges
The unique barriers healthtech companies face — and why specialized engineering expertise matters.
HIPAA & Privacy Compliance
Building PHI-safe systems with audit trails, BAA agreements, and breach notification procedures across every layer.
FDA Regulatory Navigation
Understanding SaMD classification, 510(k) pathways, predicate devices, and Design History File requirements.
Health Data Interoperability
Connecting disparate EHR systems, medical devices, and lab platforms using HL7 FHIR, DICOM, and IHE standards.
Clinical AI Validation
Proving clinical validity and safety of AI/ML models to regulators, providers, and payers — not just technical accuracy.
Medical Device Integration
Secure, reliable connectivity to 100+ medical device types with differing protocols, data formats, and security models.
Patient Engagement & Adherence
Driving sustained patient engagement, medication adherence, and behavior change through digital therapeutics.
Health Solutions
AI-Powered Medical Diagnostics
FDA-cleared machine learning models for medical imaging analysis, pathology detection, and clinical decision support.
Genomics & Precision Medicine
Whole genome sequencing analysis, variant interpretation, and pharmacogenomic insights at clinical scale.
Remote Patient Monitoring
HIPAA-compliant IoT platforms integrating wearables, medical devices, and real-time patient engagement.
Digital Therapeutics (DTx)
FDA-classified software-based medical treatments for chronic disease management and behavioral intervention.
Laboratory Information Management
LIMS platforms automating sample tracking, quality control, and clinical lab workflows at scale.
Population Health Analytics
Real-world data platforms enabling population health insights, predictive analytics, and quality benchmarking.
HealthTech Tech Stack
Client Success Stories
FDA-Cleared AI Diagnostic Platform
Medical Imaging Company (US)
Digital Therapeutics for Type 2 Diabetes
DTx Startup (EU)
Hospital RPM Platform: 50K Patients
Regional Health System (US)
Platform Capabilities
EHR & Health Platform Integrations
FDA Implementation Process
Regulatory Strategy
Define FDA classification, HIPAA requirements, intended use, and create a regulatory roadmap with submission timeline.
Clinical & Technical Architecture
Design clinical workflow integration, FHIR data models, AI/ML architecture, and security-first infrastructure.
Quality Management System
Implement QMS per ISO 13485, Design History File, Risk Management (ISO 14971), and software development lifecycle.
Clinical Validation
Conduct clinical studies, generate real-world evidence, and prepare 510(k) technical file with clinical data package.
FDA Submission & Launch
Submit 510(k) or De Novo, respond to Additional Information requests, achieve clearance, and manage post-market surveillance.
Proven Clinical ROI
Average outcomes across our healthtech client portfolio.
Client Testimonials
"Fixl guided us through the entire FDA 510(k) process while building the platform simultaneously. We achieved clearance on first submission — something rare for first-time SaMD companies."
"Their FHIR integration expertise saved us 6 months of development. They understood Epic's APIs, SMART on FHIR, and the clinical workflows better than most healthtech developers I've worked with."
"We went from Excel-based patient tracking to an enterprise RPM platform in 12 months. The HIPAA compliance framework they implemented has since passed three independent security audits."
Frequently Asked Questions
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Product Today
From concept to FDA clearance. Partner with a team that understands healthcare regulations and clinical workflows.