We provide strategic healthcare information technology consulting to bridge the gap between medical hardware, cloud infrastructure, and regulatory compliance. Whether you are a Medical Device OEM or a SaaS scale-up, we help you engineer audit-ready ecosystems.
17+
Years
in healthcare
100%
Built-in
compliance
25+
FDA & CE
approvals
ISO
13485
certified QMC
150+
Experts
in niche
Trusted by healthcare innovators worldwide
See how we help healthcare businesses turn big ideas into products that actually work.
Our services:
Strategic healthcare IT consulting
We act as your primary healthcare IT consulting company, aligning your technical roadmap with business goals. We audit existing architectures to identify bottlenecks and design scalable digital transformation strategies.
- Assess legacy infrastructure for cloud migration readiness
- Design roadmaps for digital transformation and interoperability
- Optimize IT budgets and resource allocation
- Define technical requirements for Series B+ fundraising
SaaS & software architecture consulting
Our healthcare software consulting services help product companies build resilient platforms. We design cloud-native architectures that handle high loads and ensure 99.99% uptime.
- Architect multi-tenant SaaS cores for global scaling
- Design microservices to decouple monolithic legacy systems
- Select optimal tech stacks to reduce technical debt
- Implement CI/CD pipelines for rapid feature delivery
Medical device & IoMT consulting
We provide specialized medical consulting for device manufacturers (OEMs). We guide you through the complexities of connecting physical devices to the cloud while maintaining IEC 62304 compliance.
- Design secure firmware update (OTA) mechanisms
- Architect connectivity layers for BLE and Wi-Fi sensors
- Structure technical documentation for FDA 510(k) submissions
- Mitigate risks of “bricking” life-critical devices
Interoperability & data ecosystems
We implement robust healthcare consulting solutions to eliminate data silos. We ensure your product exchanges data seamlessly with EHRs, labs, and payers using industry standards.
- Design FHIR-native APIs for real-time data exchange
- Map legacy data formats (HL7 v2) to modern standards
- Architect centralized data lakes for population health analytics
- Integrate with major EHRs (Epic, Cerner) via SMART on FHIR
Regulatory compliance & security strategy
We provide healthcare solutions focused on risk management. We implement “Compliance-as-Code” to ensure your infrastructure meets HIPAA, GDPR, and ISO 27001 requirements.
- Conduct gap analysis for ISO 13485 and SOC 2 certification
- Design Zero Trust architectures to prevent ransomware
- Automate audit logging for complete data traceability
- Prepare security documentation for hospital procurement reviews
Healthcare AI & automation strategy
We help you implement value-driven AI. We audit your data readiness and design secure ML pipelines to deploy predictive analytics without hallucinations.
- Evaluate data quality for training clinical AI models
- Design secure MLOps pipelines for continuous learning
- Implement De-identification processes for PHI safety
- Validate AI models against bias and ethical guidelines
Explore more
Get a strategic roadmap for your healthcare product
We provide a detailed execution plan to transform your vision into a technically viable, audit-ready solution.
Technologies we work with:
Rust
Kotlin
Bootloader
Linux Kernel
AWS IoT
Arduino
ESP 32
STM32
NRF52
Zephyr
LoraWan
MQTT
Standards and certifications we follow
Compliance is part of the engineering work from the first sprint. We build to the standards your auditors and regulators expect, with the documentation trail growing alongside the product.
HIPAA
GDPR and UK DPA 2018
ISO/IEC 27001
SOC 2 Type II
EU CRA (Cyber Resilience Act)
HL7 and FHI
DICOM
X12 / EDI
ISO 13485
IEC 62304
EU MDR
FDA 21 CFR 820
21 CFR Part 11
GAMP 5
DCB0129 / DCB0160
IEC 82304-1
WCAG 2.1 / 2.2 Level AA
What our clients say
Why partner with Yalantis
Proven track record in regulated environments
We leverage 15+ years of experience delivering healthcare it consulting services and solutions. We have guided 50+ products through FDA and CE approval processes, proving we understand safety-critical engineering.
Deep domain expertise
We are not just generalist healthcare it consultants. We have deep expertise in HL7/FHIR interoperability, SaMD (Software as a Medical Device) regulations, and clinical workflows, eliminating the learning curve.
Certified quality management
An ISO 13485 and ISO 27001 certified partner. We apply rigorous quality management systems to our consulting process, ensuring that our architectural recommendations are audit-ready from day one.
Bridge between Hardware & Cloud
We understand the full ecosystem. Unlike pure software agencies, we have an in-house R&D lab for IoT and firmware, allowing us to consult on complex connected health solutions.
Focus on business outcomes
We deliver healthcare it services that optimize TCO (Total Cost of Ownership). We ensure your architecture is not just technically sound but also financially viable for investors and scalable for enterprise growth.
Security-first mindset
We treat compliance as a core feature. Our strategies prioritize data privacy (HIPAA/GDPR) and cybersecurity, protecting your reputation and ensuring trust with hospital clients.
Insights into healthcare IT consulting services
Articles
HIPAA Law vs Healthcare Privacy Regulations Equivalents in other Countries
Find out the key differences in healthcare laws in the US, Canada, the UK, Australia, and MENA countries.
Articles
Healthcare business transformation: digitalize your clinical routines
Digitalization in healthcare is picking up steam. Learn how to build an all-in-one management solution that will help you optimize your clinical routines.
Articles
Benefits of remote patient monitoring and use cases for healthcare providers
Learn the present-day benefits of remote patient monitoring and use cases that can help your business elevate patient satisfaction, expand healthcare offerings, and modernize patient care approaches within your healthcare organization
FAQ
-
Do you help with FDA and MDR compliance?
Yes. Our medical it consulting team specializes in SaMD (Software as a Medical Device). We assist with technical documentation, risk management (ISO 14971), and software lifecycle processes (IEC 62304) required for FDA 510(k) and EU MDR submissions.
-
Can you assess our existing legacy software?
Absolutely. We perform comprehensive technical audits as part of our healthcare software consulting. We evaluate code quality, security vulnerabilities, and architectural scalability, providing a detailed report with modernization recommendations.
-
How do you handle interoperability challenges?
We view interoperability as a strategic advantage. We design architectures based on FHIR and HL7 standards to ensure your healthcare it solutions can seamlessly exchange data with hospitals, labs, and insurance payers.
-
Do you work with startups or enterprises?
We work with both. We help startups define their MVP architecture and compliance strategy for fundraising. For enterprises, we focus on legacy modernization, cloud migration, and scaling complex healthcare consulting solutions.
Let’s Start from call scheduling
- Schedule a call
- We collect your requirements
- We offer a solution
- We succeed together!
Welcome to Yalantis, please fill up the form and we’ll get back
Thank you for contacting us.
Keep an eye on your inbox. We’ll be in touch shortly
Meanwhile, you can explore our hottest case studies and read
client feedback on Clutch.