Healthcare product design & development services
Full-cycle engineering for medical devices, SaMD, HealthTech and smart hospitals. We bridge the gap between R&D and manufacturing, ensuring compliance, security, and scalability from day one.
Years in healthcare
Built-in compliance
FDA & CE approvals
Experts
Certified QMS
Healthcare product engineering and development services
Medical device development
SaMD development
HealthTech software development
Smart hospital solutions
Healthcare compliance & cybersecurity
Healthcare AI & data analytics
Healthcare IT consulting
Medical device development
Full-cycle engineering for connected Class II & III devices.
- Industrial design and concept development
- Hardware PCB design and prototyping
- Firmware development (Rust, C/C++)
- Compliance and security implementation
- Testing, ML integration, and manufacturing support
SaMD development
Engineering standalone regulated software for diagnostics and therapy.
- Requirements gathering and solution formulation
- Software architecture preparation and design
- Cloud and edge infrastructure development
- Mobile and web application development
- Testing and compliance certification
HealthTech software development
Creating digital tools to improve healthcare delivery and patient experience.
- End-to-end practice management software
- Custom EHR and EMR system development
- Telemedicine and virtual care platforms
- Remote care and patient portal solutions
- Revenue cycle management (RCM) tools
- Digital therapeutics (DTx) and mental health solutions
Smart hospital solutions
Modernizing clinics and hospitals through connectivity and automation.
- Smart hospital infrastructure and RTLS (Indoor positioning)
- Seamless device-to-EHR interoperability (FHIR/HL7)
- Automated clinical workflows and smart alerts
- Remote patient monitoring (RPM) integration for providers
- Asset tracking and hospital resource management
Healthcare compliance & cybersecurity
Ensuring your infrastructure and products survive audits and cyber threats.
- HIPAA, GDPR, and HITECH compliance audits and implementation
- Penetration testing and vulnerability assessment (VAPT)
- Secure cloud infrastructure setup on AWS, Azure, and GCP
- Preparation for FDA, MDR, and SOC 2 certification
- Data privacy strategy and risk management
Healthcare AI & data analytics
Transforming raw medical data into predictive insights and operational efficiency.
- Generative AI for clinical documentation and chatbots
- Predictive analytics for patient outcomes and readmissions
- Computer vision for medical imaging analysis
- NLP for unstructured clinical data processing
- Clinical decision support systems (CDSS) development
Healthcare IT consulting
Strategic guidance to navigate digital transformation and technical debt.
- Digital health technology roadmapping and strategy
- Architecture audit and technical feasibility studies
- Build vs. buy analysis and vendor selection
- Interoperability strategy and data governance
- Legacy system modernization and cloud migration planning
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Medical device development
Learn moreFull-cycle engineering for connected Class II & III devices.
- Industrial design and concept development
- Hardware PCB design and prototyping
- Firmware development (Rust, C/C++)
- Compliance and security implementation
- Testing, ML integration, and manufacturing support
-
SaMD development
Learn moreEngineering standalone regulated software for diagnostics and therapy.
- Requirements gathering and solution formulation
- Software architecture preparation and design
- Cloud and edge infrastructure development
- Mobile and web application development
- Testing and compliance certification
-
HealthTech software development
Learn moreCreating digital tools to improve healthcare delivery and patient experience.
- End-to-end practice management software
- Custom EHR and EMR system development
- Telemedicine and virtual care platforms
- Remote care and patient portal solutions
- Revenue cycle management (RCM) tools
- Digital therapeutics (DTx) and mental health solutions
-
Smart hospital solutions
Learn moreModernizing clinics and hospitals through connectivity and automation.
- Smart hospital infrastructure and RTLS (Indoor positioning)
- Seamless device-to-EHR interoperability (FHIR/HL7)
- Automated clinical workflows and smart alerts
- Remote patient monitoring (RPM) integration for providers
- Asset tracking and hospital resource management
-
Healthcare compliance & cybersecurity
Learn moreEnsuring your infrastructure and products survive audits and cyber threats.
- HIPAA, GDPR, and HITECH compliance audits and implementation
- Penetration testing and vulnerability assessment (VAPT)
- Secure cloud infrastructure setup on AWS, Azure, and GCP
- Preparation for FDA, MDR, and SOC 2 certification
- Data privacy strategy and risk management
-
Healthcare AI & data analytics
Learn moreTransforming raw medical data into predictive insights and operational efficiency.
- Generative AI for clinical documentation and chatbots
- Predictive analytics for patient outcomes and readmissions
- Computer vision for medical imaging analysis
- NLP for unstructured clinical data processing
- Clinical decision support systems (CDSS) development
-
Healthcare IT consulting
Learn moreStrategic guidance to navigate digital transformation and technical debt.
- Digital health technology roadmapping and strategy
- Architecture audit and technical feasibility studies
- Build vs. buy analysis and vendor selection
- Interoperability strategy and data governance
- Legacy system modernization and cloud migration planning
Our success stories
Technology stack
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Rust
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C
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C++
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Kotlin
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Bootloader
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Linux Kernel
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AWS IoT
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Arduino
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ESP32
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STM32
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NRF52
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Zephyr
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LoRaWAN
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MQTT
Why partner with Yalantis
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Proven track record in regulated healthcare
We deliver software for Class II & III devices and complex digital health platforms, leveraging 15+ years of experience to handle safety-critical environments where failure is not an option.
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Advanced technology & Rust expertise
From memory-safe Rust for firmware to scalable cloud architectures. We ensure 99.99% uptime and solve high-load challenges that generalist dev shops cannot handle.
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Specialized healthcare engineering teams
Scale your R&D in 2-4 weeks with engineers who understand clinical workflows. We ensure critical domain knowledge remains consistent throughout the lifecycle.
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Audit-ready security & compliance
An ISO 13485 and ISO 9001 certified partner. We align your product with FDA, MDR, HIPAA, and GDPR standards from day one to streamline certification and audits.
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End-to-end ecosystem synergy
We bridge hardware, cloud, and clinical systems. Unifying low-level firmware, patient apps, and EHR integration into a seamless, interoperable healthcare ecosystem.
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Engineered for business growth
Maximize value by optimizing device BOMs and software TCO. We ensure your product makes business sense, whether it’s a mass-produced device or a scalable SaaS platform.
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. It’s a much more interactive process, and the team at Yalantis, from the business analysts to developers, are very good at saying: “There might be a better way of doing this—why don’t you take a look at this?” 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.”
Our collaboration and engagement models
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Time and materials
– Long-term project and dynamic requirements
– Scope of work is not fully specified
– May need to alter the scope and the workload
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Fixed price
– Clear requirements and strict deadlines
– Project with a limited scope of work
– We manage the entire product development lifecycle.
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Managed team
– Yalantis provides professionals (or a whole team) with the required expertise
– We take responsibility for our specialists’ performance
– Specialists follow your corporate values and development processes -
Managed product
– Yalantis holds a wide range of responsibility, designing and co-creating a product with you
– We provide the development team for your project
– We manage the entire product development life cycle -
Managed service
– Yalantis helps you with just one or a number of services, such as design, development, QA, and DevOps
– We provide the required experts (or team of experts)
– We fully manage the entire development process
How we work on your compliant healthcare solution
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Strategy
Some clients need full development, others only regulatory support or consulting. We begin by clarifying what’s needed and what results matter most to you.
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Planning
Our team prepares a roadmap that covers everything from regulatory requirements to technical design. This gives clarity on tasks, responsibilities, and timelines.
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Execution
The agreed services are delivered by our experts. You can engage us for a single stage or involve us across the entire process.
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Support
The engagement is finalized by transferring results into practice. Ongoing support is available whenever it’s needed.
Healthcare product design & development 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.
FAQ
How do you ensure FDA, CE, and HIPAA compliance during development?
Compliance is built into every stage of our work. Our team follows established standards, prepares the required documentation, and manages submissions directly with regulators. With our product engineering services in healthcare, you can be assured that your product is developed in line with safety, quality, and data protection requirements.
What makes your healthcare product engineering services different from other providers?
Our healthcare product development company has over 15 years of experience in product engineering for healthcare. We’ve supported more than 50 FDA and CE submissions and keep a 90% first-pass approval rate. Unlike many providers, we bring together regulatory consultants and engineers, so clients get both compliance and development expertise in one place. Whether it’s medical device design, SaMD, or modernizing healthcare systems, we deliver end-to-end solutions that are fully compliant and ready for the market.
How much time does it usually take to bring a healthcare product to market with your support?
Timelines vary depending on the scope. A new medical device or SaMD can take 12–24 months to develop and certify, while shorter projects like compliance consulting or system integration may be completed in weeks or months. You can always reach our consultancy team to discuss your project and get a realistic timeframe.
Can I hire you just for one service, like regulatory consulting or EHR integration?
Yes, our healthcare product development services are flexible. Some clients engage us for full projects, while others need help with a specific stage such as compliance, platform integration, or EHR modernization. We adapt the team and scope to match your priorities
What engagement models do you offer, and how flexible are they?
We adapt to different types of projects. Some clients work with us on a fixed price basis when the scope is clear. Others choose time and materials when requirements may change. We also provide managed teams that follow your processes, or take full ownership through managed product and managed service models. However you prefer to work, our healthcare product engineering solutions can scale to fit.
How many domain experts do you have in your healthcare product development company?
Our agency brings together more than 200 engineers, designers, and regulatory specialists with direct experience in healthcare product engineering. Depending on your needs, we form dedicated teams that can handle full-cycle projects or focus on specific tasks like integration or reengineering existing healthtech solutions.
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IoT advises
How to get started with IoT development
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Get on a call with our Internet of Things product design experts.
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Tell us about your current challenges and ideas.
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We’ll prepare a detailed estimate and a business offer.
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If everything works for you, we start achieving your goals!