SaMD Development & Consulting
We help you plan, build and certify your SaMD across diagnostic, monitoring or therapeutic use cases. Get it approved with less risk and more speed.
First-try approval
Faster to market
SaMD expertise
Data compliance
Our SaMD consulting and development services
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Requirements gathering & regulatory strategy preparation
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Software architecture & design development
Types of SaMD we work with
Regulatory excellence for Software as Medical Device
Our regulatory tech stack for SaMD
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IEC 62304
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IEC 82304-1
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IEC 82304-1
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ISO 14971
Cybersecurity expertise built in
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Patient data encrypted across cloud infrastructure
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Automated SBOM generation for transparency
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Regular vulnerability testing & penetration audits
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Rust used for critical safety components
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HIPAA/GDPR-ready infrastructure & IaC enforcement
Regulatory pathways we navigate
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FDA 510(k)
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CE Mark (MDR)
How we work on your SaMD
Discovery & Regulatory Mapping
We start by defining your product’s purpose and identifying the appropriate regulatory pathway.
Architecture & Prototype Design
Next, we design the system and build early prototypes to validate core functionality and technical decisions.
Development in Iterations
We develop the product in short cycles, with regular check-ins and visible results at each stage.
Testing & Compliance Readiness
Testing and documentation are built into the process to meet FDA, MDR, IEC, and ISO requirements.
Certification & Launch Support
We prepare your technical documentation and support you through submission and regulator feedback.
Post-Market Support
After release, we handle updates, security fixes, and ongoing compliance needs.
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
Why healthcare leaders choose us for compliant SaMD solutions development
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6–12 months faster to market
Yalantis helps you move faster by applying proven regulatory strategies from day one, so your product reaches the market without unnecessary delays.
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90% first-try approval success
With our experience, you avoid common submission mistakes and reduce the risk of setbacks during regulator reviews.
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Rust-based architecture, built to last
As a SaMD development company, we develop core systems in Rust to ensure high stability and security, especially for components handling sensitive medical workflows.
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AI expertise for high-risk devices
Our engineers build intelligent features that are designed with compliance in mind, making them easier to validate and bring to market.
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Flexible models: Project Based or Dedicated Team
You get the support you need in a format that fits, whether you’re looking to extend your in-house team or fully delegate delivery.
What our clients say
Related insights
How HIPAA Relates to Healthcare Laws and Regulations Across Canada, the UK, Australia, and MENA
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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.
ISO 13485 & FDA Compliance Roadmap for Medical Device Development
Get audit-ready with our expert guide for ISO 13485 & FDA compliance. Proven strategies to avoid delays and costly rework in medical device development.
FAQ
Can you help us define the right SaMD classification and regulatory pathway?
Yes, that’s where we start. As part of our SaMD consulting services, we look at your product’s intended use and clinical role to determine the correct classification. From there, we guide you through the most suitable regulatory path, whether it’s FDA 510(k), CE Mark, or both, so you know exactly what’s ahead.
Do you cover both the technical and compliance sides of SaMD development?
Yes, we do. Your product is developed with compliance built in from the beginning. Our SaMD development services cover everything from system architecture and documentation to testing aligned with IEC 62304, ISO 13485, and other required standards.
What happens after launch? Is ongoing support available?
Yes, ongoing support is available. After your product goes live, we continue to help with updates, security improvements, and compliance maintenance. You can rely on us to keep your SaMD stable, secure, and aligned with regulatory expectations over time.
Can you help us build SaMD that integrates smoothly with EHRs or other medical systems?
Absolutely. Interoperability is a core part of how we work. Our interoperable SaMD solutions development focuses on seamless data exchange with systems like Epic, Cerner, and others, as well as medical devices and third-party systems. We make sure your product fits right into the clinical workflow from day one.
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Your steps with Yalantis
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We get on a call
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We discuss your project
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We prepare and offer you our solution
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We start our way to achieving our goals!