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%.
Years in healthcare
Built-in compliance
FDA & CE approvals
Experts
ISO Certified QMS
Our success stories
End-to-end medical device design and development
Device design & hardware engineering
Medical device firmware development
Medical device software & cloud ecosystems
Certification & compliance support
AI & TinyML integration
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
Medical device firmware development
- Secure embedded application development (Rust, C/C++)
- BSP (Board Support Package) and driver development
- RTOS integration and configuration
- Low-power connectivity implementation (BLE, Wi-Fi)
- Secure bootloader and OTA mechanism setup
Medical device software & cloud ecosystems
- Mobile applications for device management
- Scalable cloud platforms for real-time data processing
- EHR/EMR integration (HL7, FHIR, DICOM)
- Fleet management and remote provisioning
- HIPAA-compliant backend architecture
Certification & compliance support
- Regulatory strategy and certification roadmapping (FDA/CE and more)
- Comprehensive technical documentation preparation
- Risk assessments, safety validations, and device testing
- Coordination of submissions and communications with regulatory bodies
- Support for clinical trials and compliance training
- Post-certification updates and ongoing compliance management
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
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
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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
-
Medical device firmware development
- Secure embedded application development (Rust, C/C++)
- BSP (Board Support Package) and driver development
- RTOS integration and configuration
- Low-power connectivity implementation (BLE, Wi-Fi)
- Secure bootloader and OTA mechanism setup
-
Medical device software & cloud ecosystems
- Mobile applications for device management
- Scalable cloud platforms for real-time data processing
- EHR/EMR integration (HL7, FHIR, DICOM)
- Fleet management and remote provisioning
- HIPAA-compliant backend architecture
-
Certification & compliance support
- Regulatory strategy and certification roadmapping (FDA/CE and more)
- Comprehensive technical documentation preparation
- Risk assessments, safety validations, and device testing
- Coordination of submissions and communications with regulatory bodies
- Support for clinical trials and compliance training
- Post-certification updates and ongoing compliance management
-
AI & TinyML integration
Learn more- 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
-
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 work with
Connected Diabetes Care
Continuous Glucose Monitors (CGMs), insulin pumps and patch pumps, smart insulin pens, closed-loop artificial pancreas systems, bluetooth-enabled glucometers.
Wearables
Smart patches for vitals tracking and drug delivery, connected health and fitness trackers, multi-sensor activity monitors for clinical use, ECG-enabled wearables and biosensors.
Cardiac Monitoring
Ambulatory cardiac telemetry devices, implantable cardiac monitors (ICMs), smart holter monitors.
Respiratory Devices
Smart inhalers with adherence tracking, connected CPAP/BiPAP devices, nebulizers with cloud-based data logging, portable spirometers.
Diagnostic Equipment
Point-of-care testing (POCT) devices, smart stethoscopes and otoscopes, connected thermometers, oximeters, and vital sign monitors.
Therapeutic & Neuromodulation Devices
Implantable neurostimulators (spinal cord, vagus nerve), transcutaneous electrical nerve stimulation (TENS) devices, smart orthopedic braces with sensor feedback.
Infusion & Drug Delivery Devices
Smart infusion pumps (syringe, volumetric, elastomeric), implantable infusion systems, electronic auto-injectors, connected wearable injectors.
Technologies we work with
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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
How we work on your certified medical device
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Discovery & Planning
In the first phase, we provide you with a clear roadmap that reflects your goals and meets regulatory requirements.
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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.
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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.
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Testing & Compliance
Alongside development, every stage includes thorough testing and documentation, giving you dependable results and alignment with FDA, MDR, and ISO standards.
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Launch & Certification
With a fully tested product in hand, our experience with global submissions ensures it’s prepared, documented, and supported through approval.
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Post-Market Support
After release, you can count on ongoing updates, monitoring, and maintenance to keep your device safe and compliant.
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 partner with Yalantis
Proven track record
We deliver software for Class II & III medical devices, leveraging 15+ years of experience to handle safety-critical complexity where failure is not an option.
Pioneering Rust expertise for medical devices
Eliminate memory vulnerabilities in device firmware using Rust. We ensure 99.99% uptime and solving safety challenges that generalist dev shops cannot handle.
Rapid medical device engineering staffing
Scale your R&D in 2-4 weeks with specialized medical device engineers. We ensure critical domain knowledge remains consistent throughout the device lifecycle.
Audit-ready medical device security & compliance
An ISO 13485-ready partner aligning device architecture with IEC 62304 and FDA standards from day one to streamline your certification.
End-to-end medical device synergy
We bridge hardware and cloud, unifying low-level firmware, sensor data, and mobile apps into a seamless connected medical device system.
Engineered for medical device profitability
Maximize margins by optimizing device BOM costs and workflows. We ensure your product makes business sense from prototype to mass production.
Proven track record
We deliver software for Class II & III medical devices, leveraging 15+ years of experience to handle safety-critical complexity where failure is not an option.
Pioneering Rust expertise for medical devices
Eliminate memory vulnerabilities in device firmware using Rust. We ensure 99.99% uptime and solving safety challenges that generalist dev shops cannot handle.
Rapid medical device engineering staffing
Scale your R&D in 2-4 weeks with specialized medical device engineers. We ensure critical domain knowledge remains consistent throughout the device lifecycle.
Audit-ready medical device security & compliance
An ISO 13485-ready partner aligning device architecture with IEC 62304 and FDA standards from day one to streamline your certification.
End-to-end medical device synergy
We bridge hardware and cloud, unifying low-level firmware, sensor data, and mobile apps into a seamless connected medical device system.
Engineered for medical device profitability
Maximize margins by optimizing device BOM costs and workflows. We ensure your product makes business sense from prototype to mass production.
Medical devices design & development insights
How to Build a High-Quality IoT Medical Device (MIoT)
Learn what’s under the hood of the innovative IoT medical devices and how high-quality prototyping, design, quality assurance, and compliance with rigorous regulations define the future of your product.
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 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.
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Nick Orlov
IoT adviser
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!