Healthcare regulatory & compliance consulting
Accelerate market access and eliminate regulatory debt. We combine legal-grade compliance strategy with deep engineering expertise to build secure, audit-ready healthcare products from day one.
Years in healthcare
Built-in compliance
FDA & CE approvals
Experts
Certified QMS
Our services
Healthcare data privacy and security compliance
Medical device and SaMD regulatory pathways
Medicare and Medicaid reimbursement compliance
Clinical laboratory regulatory compliance
Long-term and post-acute care compliance
Healthcare data privacy and security compliance
We help healthcare software and digital health providers design, implement, and validate data protection and security controls required for handling sensitive patient information. Our team covers HIPAA security and privacy requirements end to end, from risk assessments and architecture design to audit readiness and ongoing compliance support.
Medical device and SaMD regulatory pathways
We support medical device and SaMD companies across the full regulatory journey, from early product planning to FDA submission and post-market compliance. Our experts help define the right regulatory strategy, prepare documentation, and align software development with FDA expectations to reduce approval risks and time to market.
Medicare and Medicaid reimbursement compliance
We help healthcare organizations and digital health platforms navigate CMS requirements to safely operate within Medicare and Medicaid programs. This includes compliance with reimbursement rules, reporting standards, and eligibility criteria, ensuring systems and processes are audit-ready and aligned with CMS regulations.
Clinical laboratory regulatory compliance
We assist laboratory software providers and diagnostic platforms in meeting CLIA regulatory requirements. Our team helps design compliant workflows, data handling practices, and reporting mechanisms that support laboratory operations while maintaining regulatory alignment and inspection readiness.
Long-term and post-acute care compliance
We work with hospice, home health, and long-term care providers to address regulatory requirements specific to post-acute care settings. This includes compliance around patient data privacy, care documentation, and electronic visit verification, with a focus on building systems that support both regulatory needs and day-to-day care delivery.
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Healthcare data privacy and security compliance
We help healthcare software and digital health providers design, implement, and validate data protection and security controls required for handling sensitive patient information. Our team covers HIPAA security and privacy requirements end to end, from risk assessments and architecture design to audit readiness and ongoing compliance support.
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Medical device and SaMD regulatory pathways
We support medical device and SaMD companies across the full regulatory journey, from early product planning to FDA submission and post-market compliance. Our experts help define the right regulatory strategy, prepare documentation, and align software development with FDA expectations to reduce approval risks and time to market.
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Medicare and Medicaid reimbursement compliance
We help healthcare organizations and digital health platforms navigate CMS requirements to safely operate within Medicare and Medicaid programs. This includes compliance with reimbursement rules, reporting standards, and eligibility criteria, ensuring systems and processes are audit-ready and aligned with CMS regulations.
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Clinical laboratory regulatory compliance
We assist laboratory software providers and diagnostic platforms in meeting CLIA regulatory requirements. Our team helps design compliant workflows, data handling practices, and reporting mechanisms that support laboratory operations while maintaining regulatory alignment and inspection readiness.
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Long-term and post-acute care compliance
We work with hospice, home health, and long-term care providers to address regulatory requirements specific to post-acute care settings. This includes compliance around patient data privacy, care documentation, and electronic visit verification, with a focus on building systems that support both regulatory needs and day-to-day care delivery.
Our success stories
Regulatory challenges we solve
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Navigating the “black box” of SaMD
Building Software as a Medical Device requires more than good code. It demands rigorous design controls. At Yalantis, we prevent costly re-engineering by integrating FDA software validation requirements directly into your Agile workflow, preventing launch delays.
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Interoperability vs. security
Sharing data via FHIR APIs exposes new attack surfaces. We solve the conflict between openness and privacy, ensuring your interoperability strategy meets the 21st Century Cures Act without violating HIPAA or GDPR.
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Technical debt in legacy systems
Outdated software is a compliance ticking time bomb. We re-architect legacy platforms for modern healthcare regulatory consulting, migrating on-premise data to secure, compliant cloud environments (AWS/Azure) without data loss.
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Audit fatigue & documentation chaos
Manual compliance documentation slows down release cycles. We automate the generation of trace matrices and audit logs, turning compliance from a bottleneck into a seamless background process.
Roadmap to compliance
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Requirements discovery & gap analysis
Timeline: 2-4 Weeks
Our healthcare compliance consultants assess your current architecture, code, and processes against target frameworks (HIPAA, FDA, GDPR). We deliver a detailed remediation plan prioritizing critical risks.
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Risk assessment & architecture design
Timeline: 3-6 Weeks
As part of our healthcare compliance consulting, we perform ISO 14971 risk management activities. Our architects design a secure, compliant infrastructure, defining technical controls for authentication, encryption, and data retention. -
Implementation & remediation
Timeline: Ongoing / Project-dependent
Unlike traditional firms, we write the code. We implement the necessary security patches, refactor codebases for IEC 62304 compliance, and configure cloud environments to meet HITRUST standards. -
Testing, validation & reporting
Timeline: Parallel with development
We execute automated validation protocols (IQ/OQ/PQ) for software. Our healthcare compliance consulting team generates the DHF (Design History File) or technical file required for regulatory submission or audit defense. -
Audit support & maintenance
Timeline: Continuous
Our compliance professionals stand by your side during FDA inspections or SOC 2 audits. Post-launch, we provide ongoing monitoring and healthcare compliance services to adapt to changing regulations like AI governance.
Who we help
Medical device manufacturers
For OEMs building connected devices and diagnostic software. We manage the full IEC 62304 lifecycle, FDA cybersecurity compliance, and pre-market submissions.
Hospitals & healthcare systems
For providers handling large-scale patient data. We deliver enterprise HIPAA compliance, secure cloud migration, and compliant payer interoperability.
Pharma & biotech teams
For life sciences companies digitizing R&D. We deliver lab compliance (CLIA/GLP) solutions and compliant platforms for decentralized clinical trials (DCT).
Hospice & long-term care
For specialized care providers. We build platforms that manage complex billing and patient data workflows compliant with specific hospice and long-term care regulations.
Healthtech startups
For innovators disrupting the market. We act as your fractional compliance officer, setting up your QMS and guiding you through your first regulatory submission.
Technology stack & standards
Quality management & standards
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ISO 13485
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IEC 62304
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ISO 14971
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GAMP 5
Security & privacy frameworks
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HIPAA & HITECH
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GDPR
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SOC 2 Type II
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HITRUST
Validation & documentation tools
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Jira & Confluence
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GitHub/GitLab
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DocuSign
Cloud & infrastructure compliance
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AWS Control Tower
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Azure Policy
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Terraform
Why choose Yalantis
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Engineering-first compliance
We are one of the few healthcare compliance consulting firms that can actually build what we recommend. We don’t just hand you a report; we fix the code, configuring infrastructure that is secure by design.
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ISO 13485 & 9001 certified
Our internal Quality Management System is certified for medical device development. We extend this rigor to your project, ensuring your product is built in a controlled, traceable environment from day one.
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Rust & embedded security experts
We leverage memory-safe languages like Rust for critical firmware, eliminating entire classes of security vulnerabilities before they can trigger a regulatory recall or safety incident.
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Global regulatory scope
Whether you are targeting the US (FDA), Europe (MDR/GDPR), or the UK (UKCA), our medical regulatory consultants understand the nuances of global market access and multi-jurisdictional data privacy.
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Automated compliance operations
We integrate compliance into your CI/CD pipeline. Automated testing and documentation generation mean you are always audit-ready, reducing the manual burden on your quality team.
What our clients say
The thing that has been unique in my experience working with Yalantis is that they aren’t a factory that you send over some requirements and they develop exactly to those requirements – whether good, bad, or indifferent – and then ship you back some products. They bring a really intelligent and dynamic approach to the engagement that you don’t get sometimes with other vendors.”
One of the biggest values they bring to the table is the way of thinking critically during the whole development process. They’re not just building software, they’re effectively solving your business problem.
Yalantis has been a great fit for us because of their experience, responsiveness, value, and time to market. From the very start, they’ve been able to staff an effective development team in no time and perform as expected.
Established development flows and good communication skills made collaboration with Yalantis very smooth. We appreciate their professionalism and dedication. If you are looking for a solid technical partner and a well-processed software outsourcing company for your project, I’d recommend Yalantis.
Healthcare regulatory & compliance consulting insights
How Connected Healthcare Devices Are Reshaping Care Delivery and Driving Market Growth
Learn what connected healthcare is, it’s fundamental difference from telehealth, opportunities it opens for businesses, and what it takes to develop a connected healthcare device.
HIPAA Compliance Checklist for Healthcare Software Development
This guide gives comprehensive information on how to ensure HIPAA compliance. You’ll also learn how to implement safeguards to meet the HIPAA Security Rule.
Rust for Medical Devices: Certified Software for Safety-Critical Systems
Explore how Rust can enhance medical device software with memory safety, performance, and reliability, helping developers build secure and dependable embedded systems.
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