Medical devices design &
development services
We design and develop Class II and III medical devices from concept to certification,
helping you cut time-to-market by 6 months and reduce post-market costs by 30%.
Our success stories
End-to-end medical device design and development
Device design & Hardware engineering
Firmware & Software Development
Regulations & Compliance Support
AI & TinyML Integration
Certification & Documentation Support
Manufacturing Support
Device design & Hardware engineering
- Industrial and enclosure design tailored to clinical use
- Consulting on circuit design and electrical architecture
- Prototyping and functional testing of medical equipment
- PCB design compliant with medical-grade requirements
- Component selection with regulatory and certification requirements in mind
- Preparation of full hardware documentation
Firmware & Software Development
- Secure medical device firmware programming (Rust, C/C++)
- Mobile app development for device management and monitoring
- Cloud platform engineering for real-time data aggregation and processing
- Backend architecture and API implementation
- Full ecosystem integration: device, application, and infrastructure
Regulations & Compliance Support
- Product audit and development of a certification roadmap
- Technical documentation and device testing in line with FDA/CE requirements
- Complete support with submission to regulatory authorities
- Team training on compliance standards and quality processes
- Post-certification support and documentation updates
AI & TinyML Integration
- Development of TinyML models for on-device data processing without internet dependency
- AI algorithm engineering for diagnostics and prediction based on sensor input
- Optimization of machine learning models for constrained hardware
- Compliance of AI components with 2025 FDA guidelines
- Lifecycle management: continuous learning, validation, and monitoring of AI modules
Certification & Documentation Support
- Comprehensive technical documentation for FDA/CE compliance
- Risk assessment and safety reporting
- Coordination of application submissions and regulatory communication
- Support with clinical trials and evidence collection
- Dedicated expert team managing the process from planning to certification
Manufacturing Support
- Design transfer support to contract manufacturers
- Lifecare strategy for device components
- Coordination of pilot runs and low-volume production
- Troubleshooting production challenges and yield issues
- Ongoing assistance with manufacturing audits and compliance updates
Device design & Hardware engineering
- Industrial and enclosure design tailored to clinical use
- Consulting on circuit design and electrical architecture
- Prototyping and functional testing of medical equipment
- PCB design compliant with medical-grade requirements
- Component selection with regulatory and certification requirements in mind
- Preparation of full hardware documentation
Firmware & Software Development
- Secure medical device firmware programming (Rust, C/C++)
- Mobile app development for device management and monitoring
- Cloud platform engineering for real-time data aggregation and processing
- Backend architecture and API implementation
- Full ecosystem integration: device, application, and infrastructure
Regulations & Compliance Support
- Product audit and development of a certification roadmap
- Technical documentation and device testing in line with FDA/CE requirements
- Complete support with submission to regulatory authorities
- Team training on compliance standards and quality processes
- Post-certification support and documentation updates
AI & TinyML Integration
- Development of TinyML models for on-device data processing without internet dependency
- AI algorithm engineering for diagnostics and prediction based on sensor input
- Optimization of machine learning models for constrained hardware
- Compliance of AI components with 2025 FDA guidelines
- Lifecycle management: continuous learning, validation, and monitoring of AI modules
Certification & Documentation Support
- Comprehensive technical documentation for FDA/CE compliance
- Risk assessment and safety reporting
- Coordination of application submissions and regulatory communication
- Support with clinical trials and evidence collection
- Dedicated expert team managing the process from planning to certification
Manufacturing Support
- Design transfer support to contract manufacturers
- Lifecare strategy for device components
- Coordination of pilot runs and low-volume production
- Troubleshooting production challenges and yield issues
- Ongoing assistance with manufacturing audits and compliance updates
-
Device design & Hardware engineering
- Industrial and enclosure design tailored to clinical use
- Consulting on circuit design and electrical architecture
- Prototyping and functional testing of medical equipment
- PCB design compliant with medical-grade requirements
- Component selection with regulatory and certification requirements in mind
- Preparation of full hardware documentation
-
Firmware & Software Development
- Secure medical device firmware programming (Rust, C/C++)
- Mobile app development for device management and monitoring
- Cloud platform engineering for real-time data aggregation and processing
- Backend architecture and API implementation
- Full ecosystem integration: device, application, and infrastructure
-
Regulations & Compliance Support
- Product audit and development of a certification roadmap
- Technical documentation and device testing in line with FDA/CE requirements
- Complete support with submission to regulatory authorities
- Team training on compliance standards and quality processes
- Post-certification support and documentation updates
-
AI & TinyML Integration
- Development of TinyML models for on-device data processing without internet dependency
- AI algorithm engineering for diagnostics and prediction based on sensor input
- Optimization of machine learning models for constrained hardware
- Compliance of AI components with 2025 FDA guidelines
- Lifecycle management: continuous learning, validation, and monitoring of AI modules
-
Certification & Documentation Support
- Comprehensive technical documentation for FDA/CE compliance
- Risk assessment and safety reporting
- Coordination of application submissions and regulatory communication
- Support with clinical trials and evidence collection
- Dedicated expert team managing the process from planning to certification
-
Manufacturing Support
- Design transfer support to contract manufacturers
- Lifecare strategy for device components
- Coordination of pilot runs and low-volume production
- Troubleshooting production challenges and yield issues
- Ongoing assistance with manufacturing audits and compliance updates
Types of Class II and III devices we develop
Diagnostic equipment
Point-of-care devices with cloud analytics, etc.
Wearables
Smart patches, connected health trackers, etc.
Cardiac monitoring
Remote patient monitoring systems, etc.
Respiratory devices
Smart inhalers, connected CPAPs, etc.
Connected diabetes care
CGMs, insulin pumps, smart pens, etc.
How we work on your certified medical device
-
Discovery & Planning
In the first phase, we provide you with a clear roadmap that reflects your goals and meets regulatory requirements.
-
Architecture & Prototyping
Building on that plan, our engineers deliver early prototypes and system design so you can see how the product will work before full development.
-
Development in Iterations
Once the foundation is set, you’ll see steady progress in short cycles, with working features delivered and refined at each step.
-
Testing & Compliance
Alongside development, every stage includes thorough testing and documentation, giving you dependable results and alignment with FDA, MDR, and ISO standards.
-
Launch & Certification
With a fully tested product in hand, our experience with global submissions ensures it’s prepared, documented, and supported through approval.
-
Post-Market Support
After release, you can count on ongoing updates, monitoring, and maintenance to keep your device safe and compliant.
Technologies we work with
-
Rust
-
C
-
C++
-
Kotlin
-
Bootloader
-
Linux Kernel
-
AWS IoT
-
Arduino
-
ESP32
-
STM32
-
NRF52
-
Zephyr
-
LoRaWAN
-
MQTT
What our clients say
“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.”
“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.”
“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.”
Why healthcare leaders work with us
15+ years in devices
We have been designing and engineering medical devices for more than a decade. Our track record includes 50+ FDA and CE approvals and a 90% first-pass success rate.
Regulatory expertise
We work with IEC 62304 for embedded and standalone systems, support FDA 510(k), De Novo, MDR submissions, and use a custom ISO 13485 QMS for compliance guidance.
Engineering depth
Our engineers build embedded systems in Rust, apply memory-safe architectures for safety-critical devices, support clinical validation, and align with HIPAA & GDPR.
Flexible engagement
Some clients partner with us for full device development, others extend internal teams with our experts, and many seek consulting. We adapt and support through release.
15+ years in devices
We have been designing and engineering medical devices for more than a decade. Our track record includes 50+ FDA and CE approvals and a 90% first-pass success rate.
Regulatory expertise
We work with IEC 62304 for embedded and standalone systems, support FDA 510(k), De Novo, MDR submissions, and use a custom ISO 13485 QMS for compliance guidance.
Engineering depth
Our engineers build embedded systems in Rust, apply memory-safe architectures for safety-critical devices, support clinical validation, and align with HIPAA & GDPR.
Flexible engagement
Some clients partner with us for full device development, others extend internal teams with our experts, and many seek consulting. We adapt and support through release.
Medical devices design & 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 handle integration issues with existing healthcare systems?
Challenges in medical device software development often originate from poor vendor documentation or integrating multiple devices. We handle this by working with vendors directly or suggesting better-documented alternatives. For multi-device setups, we merge and normalize data to ensure smooth processing. Every project is unique, so issues may vary.
Can you assist with FDA or MDR compliance for medical device software?
Yes. We provide software design for medical devices in line with FDA and MDR regulations, as well as ISO 13485 and IEC 62304 standards, to support smooth approvals and safe releases. That applies to software development for medical devices as well.
Do you develop Software as a Medical Device (SaMD)?
That’s what we do! We offer medical device software engineering for SaMD products, from risk analysis and UI design to cloud connectivity and compliance.
Can you integrate medical devices with EHR or hospital systems?
We can. Yalantis is a medical device design firm that also delivers medical device interoperability services, supporting integration with EHRs, hospital platforms, and HL7/FHIR standards.
How do you ensure the interoperability of connected medical devices?
We develop medical device software solutions that standardize and synchronize data across various devices, so the data exchange is smooth and compliant.
Do you provide validation and verification services for medical software?
Yes, we do it as part of our medical device software development services. We conduct strict verification and validation (V&V) testing to ensure software safety, reliability, and compliance.
What is your experience with healthcare and medtech interoperability?
We’ve delivered medical device engineering services for all classes of FDA-approved devices and built custom medical device solutions from scratch solutions from scratch. The experts from Yalantis develop medical device software for diagnostics, remote monitoring, and chronic disease management, offering medical device software consulting and ongoing medical device software outsourcing when needed. This makes us a long-term partner for healthcare companies that require seamless data integration and dependable outcomes.
Contact us
got it!
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.
Nick Orlov
IoT adviser
How to get started with IoT development
-
Get on a call with our Internet of Things product design experts.
-
Tell us about your current challenges and ideas.
-
We’ll prepare a detailed estimate and a business offer.
-
If everything works for you, we start achieving your goals!