Healthcare Product Design & Development Services
We develop medical devices, engineer healthcare software, and handle compliance from day one. By aligning hardware, firmware, cloud, and certification, Yalantis helps you launch faster and reduce post-market costs up to 30%.
Years in healthcare
Built-in compliance
FDA & CE approvals
Experts
Certified QMS
Our success stories
Healthcare product engineering and development services
Medical device development
SaMD development
Custom regulations and compliance support
Custom EHR software development & interoperability
AI integration in medical products
Medical device development
- 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
- Requirements gathering and solution formulation
- Software architecture preparation and design
- Cloud and edge infrastructure development
- Mobile and web application development
- Testing and compliance certification
Custom regulations and compliance support
- Quality Management System implementation (ISO 13485)
- Regulatory submission prep, specialized technical writing, and authority liaison
- Gap analysis and market entry strategy (FDA/CE/HIPAA/Health Canada)
- Design History File, verification/validation, and ISO 14971 risk management
- Compliance training and process optimization
Custom EHR software development & interoperability
- EHR/EMR development with specialty-specific workflows and documentation
- Integration with Epic, Cerner, AllScripts, and athenahealth
- SMART on FHIR apps with OAuth 2.0 and clinical decision support
- Clinical data warehouses with HIPAA-compliant analytics and reporting
- Legacy system modernization and API development for cloud-native architecture
AI integration in medical products
- Machine learning models for diagnostics and predictive analytics
- AI algorithm integration into existing systems and products
- FDA SaMD regulatory guidance and submission support
- Tiny ML development for medical devices
Medical device development
- 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
- Requirements gathering and solution formulation
- Software architecture preparation and design
- Cloud and edge infrastructure development
- Mobile and web application development
- Testing and compliance certification
Custom regulations and compliance support
- Quality Management System implementation (ISO 13485)
- Regulatory submission prep, specialized technical writing, and authority liaison
- Gap analysis and market entry strategy (FDA/CE/HIPAA/Health Canada)
- Design History File, verification/validation, and ISO 14971 risk management
- Compliance training and process optimization
Custom EHR software development & interoperability
- EHR/EMR development with specialty-specific workflows and documentation
- Integration with Epic, Cerner, AllScripts, and athenahealth
- SMART on FHIR apps with OAuth 2.0 and clinical decision support
- Clinical data warehouses with HIPAA-compliant analytics and reporting
- Legacy system modernization and API development for cloud-native architecture
AI integration in medical products
- Machine learning models for diagnostics and predictive analytics
- AI algorithm integration into existing systems and products
- FDA SaMD regulatory guidance and submission support
- Tiny ML development for medical devices
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Medical device development
Learn more- 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 more- Requirements gathering and solution formulation
- Software architecture preparation and design
- Cloud and edge infrastructure development
- Mobile and web application development
- Testing and compliance certification
-
Custom regulations and compliance support
- Quality Management System implementation (ISO 13485)
- Regulatory submission prep, specialized technical writing, and authority liaison
- Gap analysis and market entry strategy (FDA/CE/HIPAA/Health Canada)
- Design History File, verification/validation, and ISO 14971 risk management
- Compliance training and process optimization
-
Custom EHR software development & interoperability
Learn more- EHR/EMR development with specialty-specific workflows and documentation
- Integration with Epic, Cerner, AllScripts, and athenahealth
- SMART on FHIR apps with OAuth 2.0 and clinical decision support
- Clinical data warehouses with HIPAA-compliant analytics and reporting
- Legacy system modernization and API development for cloud-native architecture
-
AI integration in medical products
- Machine learning models for diagnostics and predictive analytics
- AI algorithm integration into existing systems and products
- FDA SaMD regulatory guidance and submission support
- Tiny ML development for medical devices
Why healthcare innovators work with us
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15+ years in healthcare
We have delivered healthcare software and devices for more than a decade and secured over 50 FDA and CE approvals. Our clients include startups, hospitals, and international device manufacturers.
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Full-cycle engineering
Our team covers hardware, firmware, mobile apps, cloud platforms, and data analytics under one roof. We also connect new products with Epic and Cerner so they fit naturally into clinical workflows.
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Proven regulatory results
90% of submissions we support pass on the first attempt. By embedding FDA, CE, HIPAA, and GDPR compliance from the beginning, we help shorten review times and protect sensitive healthcare data.
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Flexible engagement
Some clients rely on us for complete project delivery, others extend their in-house teams with our engineers, and many choose focused consulting. In every model, pricing is transparent and support continues through market release.
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.”
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
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 Engineering & Development Insights
A proven approach to medical device software development: How to build a feasible software prototype, test it, and successfully launch your product
HIPAA compliance checklist for 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
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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Nick Orlov
Engagement Manager
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!