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.

Yalantis
Industries
Healthcare IT consulting

Healthcare IT Consulting Services Request a consultation

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.

Trusted by healthcare innovators worldwide

See how we help healthcare businesses turn big ideas into products that actually work.

Our Success Stories

Medical Device Prototyping and Healthcare App Development for Better Patient Data Connectivity

IoT and remote patient monitoring functionality for a telehealth platform.

AI App and IoT Integration for Medical Device Manufacturer Leads to 30% Revenue Growth

An AI-powered mobile app that syncs clients’ ECG and pulse oximeter wearables with clinic systems across the U.S.

Integrating smartwatches and fitness devices

Wearables integration with Apple Watch, Fitbit, Withings for remote patient monitoring and health data aggregation.

SaMD Solution for Accurate Medication Dosage Calculation

Reducing medication errors by developing a Software as a Medical Device (SaMD) product that calculates the optimal medication dosage for each individual patient.

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.

Get your roadmap

Technologies we work with:

Rust

Kotlin

Bootloader

Linux Kernel

AWS IoT

Arduino

ESP 32

STM32

NRF52

Zephyr

LoraWan

MQTT

What our clients say

Yalantis isn’t a factory that you send over some requirements and they develop exactly to those requirements. They bring a really intelligent and dynamic approach to the engagement that you don’t get sometimes with other vendors.

Simon Jones, CIO in Healthcare

What fascinated me the most is how invested the Yalantis development team is, and how they often exceeded expectations in what we were trying to accomplish in terms of timeframes.

Sérgio Miguel Vieira, Founder and CEO

They have very good organization and project management expertise. We’re not just getting the developers, we’re getting a whole support structure. Also, Yalantis cares about their employee satisfaction. And with satisfied employees, we get much better output.

Sergei Lishchenko, Director of Digital Experience

What triggered us was their remote collaboration practices as well as their experience in the IoT industry. Their strong technical experience helped us scale our platform and deliver great performance to our customers.

Roy, Partner at RAKwireless

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.

Ron Bullis, President and Founder at Lifeworks Advisors

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.

Mark Boudreau, Founder and COO at Healthfully

Established development flows and good communication skills made collaboration with Yalantis very smooth. If you are looking for a professional, dedicated and a solid technical partner and a well-processed software outsourcing company for your project, I’d recommend Yalantis.

Ken Yu, CEO at RAKwireless

Working with Yalantis, you get their breadth of experience building hundreds of projects. Their expertise and knowledge were second to none. And that makes the difference between a good product and a great product.

Andrew Gazdecki, CEO at MicroAcquire

With the product built by Yalantis, we have a lot of possibilities for growth. They elaborated a great user experience for our operators to work more efficiently and properly deal with troubleshooting. And the architecture of the product is scalable and ready for the future.

Alejandro Resendiz, General manager at 123 Sourcing

Learn more

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

HIPAA vs Healthcare Laws and Regulations in Canada, the UK, Australia, and MENA Countries

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How HIPAA Relates to Healthcare Laws and Regulations Across Canada, the UK, Australia, and MENA

Find out the key differences in healthcare laws in the US, Canada, the UK, Australia, and MENA countries.

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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.

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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.

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