SaMD Development & Consulting

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.

Book a consultation
90%

First-try approval

6–12 months

Faster to market

Class I, IIa, IIb, III

SaMD expertise

HIPAA / GDPR

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

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Secure cloud & edge infrastructure setup for SaMD

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Clinical-grade AI models integrations and development

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Healthcare ecosystem & EHR/EMR integration

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Patient & clinician-focused application development

Requirements gathering & regulatory strategy preparation

  • Clinical needs analysis
  • SaMD risk classification (Class I/IIa/IIb/III)
  • Regulatory pathway selection (FDA 510(k), CE MDR)

What you achieve with Yalantis: A clear custom go-to-market plan from our top SaMD consultants and up to 6-12 months saved on your launch timeline

Requirements gathering & regulatory strategy preparation

​​Software architecture & design development

  • IEC 62304 compliant architecture
  • ISO 13485–aligned design controls
  • FDA-ready software design and traceability
  • Cybersecurity-by-design (IEC 81001-5-1)
  • Scalability for clinical workloads

What you achieve with Yalantis: Architecture ready for FDA or Notified Body audits.

 

​​Software architecture & design development

Secure cloud & edge infrastructure setup for SaMD

  • HIPAA/GDPR-compliant cloud architecture
  • Edge computing for real-time clinical data
  • Medical data encryption & security
  • Infrastructure as Code (IaC) for compliance

What you achieve with Yalantis: Safe and compliant infrastructure for clinical data.

 

Secure cloud & edge infrastructure setup for SaMD

Clinical-grade AI models integrations and development

  • Validated AI models for medical diagnosis
  • Model explainability for regulators
  • FDA AI/ML compliance (Predetermined Change Control)

What you achieve with Yalantis: AI models validated for clinical use and regulatory approval.

 

Secure cloud & edge infrastructure setup for SaMD

Healthcare ecosystem & EHR/EMR integration

  • FHIR/HL7 EHR connectivity (Epic, Cerner, Allscripts)
  • HIPAA/GDPR-compliant cloud infrastructure (AWS, Azure)
  • Medical device data integration

What you achieve with Yalantis: Smooth integration with clinical systems and workflows.

 

Healthcare ecosystem & EHR/EMR integration

Patient & clinician-focused application development

  • Medical-grade mobile apps (iOS/Android)
  • Web-based clinical interfaces
  • Patient engagement portals with telehealth

What you achieve with Yalantis: Easy-to-use apps for patients and clinicians.

Patient & clinician-focused application development
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Requirements gathering & regulatory strategy preparation

  • Clinical needs analysis
  • SaMD risk classification (Class I/IIa/IIb/III)
  • Regulatory pathway selection (FDA 510(k), CE MDR)

What you achieve with Yalantis: A clear custom go-to-market plan from our top SaMD consultants and up to 6-12 months saved on your launch timeline

Requirements gathering & regulatory strategy preparation
icon

​​Software architecture & design development

  • IEC 62304 compliant architecture
  • ISO 13485–aligned design controls
  • FDA-ready software design and traceability
  • Cybersecurity-by-design (IEC 81001-5-1)
  • Scalability for clinical workloads

What you achieve with Yalantis: Architecture ready for FDA or Notified Body audits.

 

​​Software architecture & design development
Icon

Secure cloud & edge infrastructure setup for SaMD

  • HIPAA/GDPR-compliant cloud architecture
  • Edge computing for real-time clinical data
  • Medical data encryption & security
  • Infrastructure as Code (IaC) for compliance

What you achieve with Yalantis: Safe and compliant infrastructure for clinical data.

 

Secure cloud & edge infrastructure setup for SaMD
icon

Clinical-grade AI models integrations and development

  • Validated AI models for medical diagnosis
  • Model explainability for regulators
  • FDA AI/ML compliance (Predetermined Change Control)

What you achieve with Yalantis: AI models validated for clinical use and regulatory approval.

 

Secure cloud & edge infrastructure setup for SaMD
icon

Healthcare ecosystem & EHR/EMR integration

  • FHIR/HL7 EHR connectivity (Epic, Cerner, Allscripts)
  • HIPAA/GDPR-compliant cloud infrastructure (AWS, Azure)
  • Medical device data integration

What you achieve with Yalantis: Smooth integration with clinical systems and workflows.

 

Healthcare ecosystem & EHR/EMR integration
icon

Patient & clinician-focused application development

  • Medical-grade mobile apps (iOS/Android)
  • Web-based clinical interfaces
  • Patient engagement portals with telehealth

What you achieve with Yalantis: Easy-to-use apps for patients and clinicians.

Patient & clinician-focused application development
  • icon

    Requirements gathering & regulatory strategy preparation

    • Clinical needs analysis
    • SaMD risk classification (Class I/IIa/IIb/III)
    • Regulatory pathway selection (FDA 510(k), CE MDR)

    What you achieve with Yalantis: A clear custom go-to-market plan from our top SaMD consultants and up to 6-12 months saved on your launch timeline

    Requirements gathering & regulatory strategy preparation
  • icon

    ​​Software architecture & design development

    • IEC 62304 compliant architecture
    • ISO 13485–aligned design controls
    • FDA-ready software design and traceability
    • Cybersecurity-by-design (IEC 81001-5-1)
    • Scalability for clinical workloads

    What you achieve with Yalantis: Architecture ready for FDA or Notified Body audits.

     

    ​​Software architecture & design development
  • Icon

    Secure cloud & edge infrastructure setup for SaMD

    • HIPAA/GDPR-compliant cloud architecture
    • Edge computing for real-time clinical data
    • Medical data encryption & security
    • Infrastructure as Code (IaC) for compliance

    What you achieve with Yalantis: Safe and compliant infrastructure for clinical data.

     

    Secure cloud & edge infrastructure setup for SaMD
  • icon

    Clinical-grade AI models integrations and development

    • Validated AI models for medical diagnosis
    • Model explainability for regulators
    • FDA AI/ML compliance (Predetermined Change Control)

    What you achieve with Yalantis: AI models validated for clinical use and regulatory approval.

     

    Secure cloud & edge infrastructure setup for SaMD
  • icon

    Healthcare ecosystem & EHR/EMR integration

    • FHIR/HL7 EHR connectivity (Epic, Cerner, Allscripts)
    • HIPAA/GDPR-compliant cloud infrastructure (AWS, Azure)
    • Medical device data integration

    What you achieve with Yalantis: Smooth integration with clinical systems and workflows.

     

    Healthcare ecosystem & EHR/EMR integration
  • icon

    Patient & clinician-focused application development

    • Medical-grade mobile apps (iOS/Android)
    • Web-based clinical interfaces
    • Patient engagement portals with telehealth

    What you achieve with Yalantis: Easy-to-use apps for patients and clinicians.

    Patient & clinician-focused application development

Types of SaMD we work with

Diagnostic SaMD

Software that detects diseases, conditions, or clinical signs (Class I/IIa – Class IIb/III)

• AI model for melanoma detection from smartphone images
• Lung cancer risk scoring based on CT scan data
• Digital tool for early dementia screening using memory and speech tasks
• Smartphone otoscope with diagnostic support
• Eye disease detection from retinal scans
• AI triage chatbot for preliminary symptom assessment
• AI-based analysis of pap smear or cervical cytology

Diagnostic SaMD

Monitoring SaMD

Software that tracks physiological parameters or predicts health risks (Class IIa – Class IIb)

• ECG-based algorithm to predict heart failure or arrhythmia
• Blood glucose monitoring companion apps for diabetics
• Post-operative remote patient monitoring system
• Wearable-integrated asthma risk alert app
• Blood pressure tracking app with risk insights
• Neurological status monitoring for epilepsy patients
• Pregnancy monitoring with contraction pattern analysis

Monitoring SaMD

Therapeutic SaMD

Software that delivers or supports treatment, or substitutes clinical procedures (Class IIb – Class III)

• DTx app for treating anxiety or depression (e.g. CBT-based)
• AI tool for optimizing chemotherapy dosage
• Neuromodulation control via app and wearable combo
• Mobile app for chronic pain self-management
• App for behavioral therapy in ADHD
• Digital coach for Type 2 diabetes lifestyle interventions
• App-based rehabilitation therapy for stroke recovery

Therapeutic SaMD

Regulatory excellence for Software as Medical Device

Our regulatory tech stack for SaMD

  • IEC logo

    IEC 62304

  • IEC logo

    IEC 82304-1

  • IEC logo

    IEC 82304-1

  • ISO logo

    ISO 14971

Cybersecurity expertise built in

  • Cloud infrastructure logo

    Patient data encrypted across cloud infrastructure

  • Automated SBOM logo

    Automated SBOM generation for transparency

  • Regular vulnerability testing logo

    Regular vulnerability testing & penetration audits

  • Rust logo

    Rust used for critical safety components

  • HIPAA/GDPR logo

    HIPAA/GDPR-ready infrastructure & IaC enforcement

Regulatory pathways we navigate

  • FDA 510(k) logo

    FDA 510(k)

  • CE Mark logo

    CE Mark (MDR)

How we work on your SaMD

point 1

Discovery & Regulatory Mapping

We start by defining your product’s purpose and identifying the appropriate regulatory pathway.

point 2

Architecture & Prototype Design

Next, we design the system and build early prototypes to validate core functionality and technical decisions.

point 3

Development in Iterations

We develop the product in short cycles, with regular check-ins and visible results at each stage.

Point 4

Testing & Compliance Readiness

Testing and documentation are built into the process to meet FDA, MDR, IEC, and ISO requirements.

Point 5

Certification & Launch Support

We prepare your technical documentation and support you through submission and regulator feedback.

Point 6

Post-Market Support

After release, we handle updates, security fixes, and ongoing compliance needs.

point 1

Discovery & Regulatory Mapping

We start by defining your product’s purpose and identifying the appropriate regulatory pathway.

point 2

Architecture & Prototype Design

Next, we design the system and build early prototypes to validate core functionality and technical decisions.

point 3

Development in Iterations

We develop the product in short cycles, with regular check-ins and visible results at each stage.

Point 4

Testing & Compliance Readiness

Testing and documentation are built into the process to meet FDA, MDR, IEC, and ISO requirements.

Point 5

Certification & Launch Support

We prepare your technical documentation and support you through submission and regulator feedback.

Point 6

Post-Market Support

After release, we handle updates, security fixes, and ongoing compliance needs.

Technologies we work with

  • Rust

  • C

  • C++

  • Kotlin

  • Bootloader

  • Linux Kernel

  • AWS IoT

  • Arduino

  • ESP32

  • STM32

  • NRF52

  • Zephyr

  • LoRaWAN

  • 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

“Yalantis isn’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. 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.”

Simon Jones

CIO in Healthcare

“What fascinated me the most is how invested the Yalantis development team is, and how they often exceeded expectations in what we were trying to accomplish in terms of timeframes.”

Sérgio Miguel Vieira

Founder and CEO

“They have very good organization and project management expertise. We’re not just getting the developers, we’re getting a whole support structure. Also, Yalantis cares about their employee satisfaction. And with satisfied employees, we get much better output.”

Sergei Lishchenko

Director of Digital Experience

“What triggered us was their remote collaboration practices as well as their experience in the IoT industry. Their strong technical experience helped us scale our platform and deliver great performance to our customers.”

Roy

Partner at RAKwireless

“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.”

Ron Bullis

President and Founder at Lifeworks Advisors

“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.”

Mark Boudreau

Founder and COO at Healthfully

“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.”

Ken Yu

CEO at RAKwireless

“Working with Yalantis, you get their breadth of experience building hundreds of projects. Their expertise and knowledge were second to none. And that makes the difference between a good product and a great product.”

Andrew Gazdecki

CEO at MicroAcquire

“With the product built by Yalantis, we have a lot of possibilities for growth. They elaborated a great user experience for our operators to work more efficiently and properly deal with troubleshooting. And the architecture of the product is scalable and ready for the future.”

Alejandro Resendiz

General manager at 123 Sourcing

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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    Nick Orlov

    Engagement Manager

    Your steps with Yalantis

    • We get on a call

    • We discuss your project

    • We prepare and offer you our solution

    • We start our way to achieving our goals!