90-Day Healthcare and MedTech DevOps Transformation | Stonetusker Systems
Healthcare and MedTech DevOps

GDPR, HIPAA-Compliant. FDA-Ready.
Patient-First in 90 Days.

HIPAA-compliant CI/CD, FDA medical device pipelines, telehealth infrastructure, and AI diagnostics built for hospitals, digital health platforms, and medical device manufacturers. Deploy daily with full compliance and 99.9% uptime.

70% Faster Deployments
100% HIPAA and FDA Compliant
99.9% Healthcare Uptime
Zero PHI Breaches
AI Diagnostics Production-Ready
Unlimited Telehealth Scalability
Get Your Free Audit Request Your 90-Day Plan
AES-256 Encryption for All PHI Data
RTO Under 1hr Disaster Recovery for Patient Systems
IEC 62304 Medical Device Software Lifecycle
21 CFR Part 820 FDA SaMD Design Controls Automated
60-Day HIPAA Breach Notification Automated
The Transformation

What Stonetusker Delivers

Comprehensive healthcare DevOps proven across hospitals, digital health platforms, medical device manufacturers, and diagnostic labs worldwide. Every engagement starts with a genuine audit of your compliance posture and delivery pipeline today.

01
HIPAA-Compliant CI/CD
Automated audit logging, PHI access controls, OCR-ready evidence generation, and HITRUST CSF controls for every pipeline stage.
02
EMR and EHR Pipelines
Zero-downtime deployments for patient-facing applications with FHIR and HL7 integration connecting to Epic, Cerner, and 5000 plus healthcare providers.
03
FDA Medical Device DevOps
21 CFR Part 820, IEC 62304, and ISO 13485 compliant pipelines with automated design controls, traceability matrices, and premarket submission packages.
04
Telehealth Infrastructure
Cloud-native microservices for patient surges, HIPAA-compliant video with end-to-end encryption, and consent management automation at scale.
05
AI Diagnostics and MLOps
FDA-validated medical imaging AI pipelines, DICOM integration with PACS systems, federated learning for multi-hospital training, and clinical model monitoring.
06
Security and PHI Protection
AES-256 encryption with HSM key management, role-based access with minimum necessary enforcement, automated penetration testing, and post-market surveillance.
Days 1 to 30 01

HIPAA-Compliant Foundation.

Build audit-proof healthcare systems from day one. HIPAA Security Rule compliance, PHI protection, FHIR and HL7 integration, and encrypted infrastructure across your full cloud environment.

  • Complete HIPAA compliance audit mapping to Security Rule technical, administrative, and physical safeguards across your current systems and cloud environment. Gap analysis complete. Roadmap to full compliance in 90 days.
  • HIPAA-compliant CI/CD pipelines with automated audit logging and PHI access controls so every deployment generates OCR-ready evidence automatically. Every deployment traced. OCR audit-ready on demand.
  • EMR and EHR system CI/CD with zero-downtime deployments enabling critical fixes to be pushed during business hours without any patient data exposure risk. Deploy critical fixes live. Zero patient data exposure.
  • FHIR and HL7 integration pipelines for interoperability with Epic, Cerner, and hospital information systems across the healthcare network. Standards-compliant exchange. Connect to 5000 plus providers.
  • Encryption at rest and in transit with centralised key management through AWS KMS, Azure Key Vault, or hardware security modules for all PHI workloads. AES-256 for all PHI. HIPAA encryption requirements exceeded.
  • Access control automation with role-based access and minimum necessary principle enforcement ensuring clinicians see only the patient data required for care. Minimum necessary enforced. Audit trail for every access.
  • Business Associate Agreement automation for all cloud services, with continuous compliance validation and documentation maintained without manual effort. All cloud vendors BAA-compliant. Documentation always current.
  • Automated PHI backup and disaster recovery with encrypted multi-region replication, tested failover, and defined RTO and RPO targets for every system. RTO under 1 hour. RPO under 15 minutes. Patient data never lost.
  • Breach notification procedures automation covering detection, containment, investigation, and 60-day HIPAA compliance notification timelines without manual coordination. Full incident workflow automated. Compliant within 60 days.
  • HITRUST CSF controls implementation for advanced healthcare compliance certification that goes beyond the HIPAA baseline and meets enterprise healthcare buyer requirements. Beyond HIPAA baseline. Enterprise buyer requirements met.
Days 31 to 60 02

Medical Devices and Telehealth.

Deploy medical device software safely and scale telehealth infrastructure to meet any demand. FDA 21 CFR Part 820, IEC 62304, secure OTA firmware updates, and cloud-native telehealth at enterprise scale.

  • FDA 21 CFR Part 820 compliant CI/CD for Software as a Medical Device and Software in a Medical Device with automated design controls, verification, and validation for premarket submissions. FDA premarket submissions automated. Design controls verified.
  • IEC 62304 medical device software lifecycle with full traceability matrix from requirements through to test, covering Class A, B, and C software safety classifications. Class A through C coverage. Requirements-to-test traceability automated.
  • Embedded medical device CI/CD with Yocto Linux for imaging systems, patient monitors, and infusion pumps including real-time OS integration and hardware-in-the-loop testing. FDA-validated toolchain. Real hardware tested on every commit.
  • Secure OTA updates for deployed medical devices using A/B partition updates with post-market surveillance records maintained automatically for FDA compliance. Push critical fixes to devices in the field. Surveillance records automated.
  • ISO 13485 quality management system integration with automated documentation generation ensuring notified body audits are passed on the first submission. Medical device manufacturing standards met. First-pass audit ready.
  • Risk management per ISO 14971 with automated hazard analysis and risk assessment integrated into CI/CD so safety documentation stays current with every code change. FMEA integrated into pipeline. Safety docs always current.
  • Telehealth platform scaling with cloud-native microservices and auto-scaling architecture designed to handle 10x traffic spikes during peak demand or public health events. 10x surge capacity. 99.9% video consultation uptime guaranteed.
  • HIPAA-compliant video infrastructure with WebRTC security hardening, BAA-compliant hosting, and end-to-end encryption for every patient consultation. WebRTC hardened. Zero PHI exposure in video sessions.
  • Patient consent management automation with full audit trails ensuring GDPR and HIPAA consent requirements are enforced system-wide without manual processes. Consent requirements enforced automatically across all systems.
  • Medical device cybersecurity per FDA premarket guidance with threat modelling, Software Bill of Materials generation, and automated vulnerability patching for deployed devices. Supply chain security automated. Deployed devices patched safely.
  • Clinical decision support systems deployment with real-time EHR integration delivering AI-powered alerts at point of care with sub-second drug interaction warning latency. Sub-second clinical alerts. Drug interactions caught at point of care.
Days 61 to 90 03

AI Diagnostics and Elite Performance.

Deploy AI-powered diagnostics safely into production, build self-healing healthcare systems, and achieve sustained compliance excellence with continuous monitoring and team enablement.

  • AI diagnostics MLOps pipelines for medical imaging with FDA regulatory validation, enabling radiology AI models to go into production while meeting SaMD requirements. Radiology AI in production. FDA SaMD requirements met.
  • Clinical model monitoring with drift detection and performance degradation alerts ensuring diagnostic accuracy is maintained post-deployment with automatic retraining on distribution shift. Diagnostic accuracy maintained. Auto-retraining on distribution shift.
  • DICOM integration pipelines for medical imaging AI with PACS system connectivity enabling AI inference results to flow directly back into radiologist workflows. AI results in radiologist workflow. Secure PACS connectivity.
  • Federated learning infrastructure for multi-hospital AI training allowing models to be trained across distributed patient datasets without any PHI leaving individual institutions. Train across hospitals. PHI never centralised. HIPAA-compliant ML.
  • Clinical trial software platforms with 21 CFR Part 11 electronic records compliance covering audit trails, e-signatures, and data integrity controls for research systems. Audit trails, e-signatures, data integrity. FDA research-ready.
  • Wearable device data pipelines ingesting real-time vitals from 100,000 plus devices with clinical threshold monitoring and instant clinical notification on alert conditions. 100K plus wearables ingested. Clinical alerts in real time.
  • Genomics data pipelines with secure storage for precision medicine applications and HIPAA-compliant bioinformatics workflows built for terabyte-scale genomic datasets. Terabyte-scale genomics. HIPAA-compliant bioinformatics automated.
  • Population health analytics with HIPAA Safe Harbor de-identification pipelines generating continuous research datasets without manual data governance overhead. Safe Harbor de-identification automated. Research datasets generated continuously.
  • Custom DORA metrics for healthcare tracking deployment frequency alongside compliance maintenance rates so engineering velocity and regulatory standing are measured together. Weekly EMR updates. 100% HIPAA compliance maintained.
  • Zero-downtime database migrations for patient data with backwards compatibility built in so EHR schemas can evolve without ever disrupting active clinical workflows. Schema changes with no service interruption. Clinical workflows unaffected.
  • Automated penetration testing for patient portals and mobile health applications with continuous OWASP Top 10 vulnerability scanning and remediation. Security validated continuously. OWASP Top 10 eliminated.
  • Patient data request automation for HIPAA Right of Access compliance ensuring patients receive their medical records within the 30-day statutory requirement without manual effort. 30-day Right of Access met. Fully automated patient records workflow.
  • Post-market surveillance automation for medical devices with FDA MedWatch reporting integrated so adverse event reporting happens automatically across all deployed devices. MedWatch reporting automated. Device performance tracked fleet-wide.
  • Interoperability with Apple Health, Google Fit, and patient-generated health data sources providing a unified patient view with consumer wearables in clinical workflows. Unified patient view. Consumer wearables in clinical workflows.
  • Team enablement through HIPAA Security Rule training, FDA medical device workshops, and healthcare AI compliance preparation building lasting in-house expertise. Engineers certified in healthcare compliance. 80% faster regulatory approvals.
  • Healthcare API rate limiting and DDoS protection for all patient-facing services ensuring critical health systems remain available even during targeted cyber attacks. Patient systems protected and always available. OWASP Top 10 eliminated.
  • Full handover with HIPAA policies, FDA design control templates, medical device validation documentation, and a 12-month roadmap so the transformation continues independently. Self-sufficient healthcare DevOps. Scale to new markets independently.
Proven Results

Delivered Worldwide

70% Faster Deployments
100% HIPAA and FDA Compliant
99.9% Healthcare Uptime
Zero PHI Breaches
AI Diagnostics in Production
Unlimited Telehealth Scalability

Ready to Build
Compliant Healthcare DevOps?

Start with a free healthcare audit. We will review your current HIPAA posture, medical device compliance gaps, and deployment pipeline in the first conversation, at no cost and with no commitment required.

Get Your Free Audit Email Us Directly
No long-term contracts Pilot-first engagement Results in 90 days NDA from day one