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.
SaMD Development & Consulting
90%
First-try
approval
6–12
Months faster
to market
I, II, III
Class
SaMD expertise
HIPAA / GDPR
Data
compliance
IEC
62304
ISO
13485
Real projects. Real outcomes.
These projects show what our SaMD development looks like in practice: different clinical use cases and risk classes, same approach. We understand the clinical context first, then build software that holds up in the clinic and in the audit.
Our SaMD consulting and development services
Compliance & security
We define how your software will be regulated before development starts, then build the evidence alongside the product. Work runs under our ISO 13485-certified QMS, and we document your SaMD against IEC 62304, IEC 82304-1, ISO 14971, IEC 62366-1, IEC 81001-5-1, FDA 21 CFR 820 (QMSR) and Part 11, FDA premarket cybersecurity requirements, EU MDR and IVDR, UK MDR (UKCA), HIPAA and GDPR. For AI-based SaMD we also cover FDA PCCP guidance, Good Machine Learning Practice and the EU AI Act.
Clinical needs analysis and intended use statement
- SaMD qualification and risk classification: FDA Class I–III, EU MDR Rule 11 (Class I–III), IVDR Class A–D for diagnostic software, IMDRF risk categories
- Regulatory pathway selection: FDA 510(k), De Novo or PMA; CE marking under EU MDR or IVDR; UKCA
- IEC 62304 software safety classification and lifecycle documentation
- ISO 14971 risk management file and IEC 62366-1 usability engineering file
- Cybersecurity documentation for FDA and Notified Body review: threat model, SBOM, security testing
- Clinical safety case for NHS deployment (DCB0129)
- Technical documentation and FDA eSTAR inputs; support with regulator questions
What you achieve with Yalantis: A clear go-to-market plan from our SaMD consultants and up to 6–12 months saved on your launch timeline.
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.
Cloud & edge infrastructure setup
- 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.
Medical AI engineering
- 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.
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.
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.
Our compliance
Types of SaMD we work with
Diagnostic SaMD (Risk Classes: I – III)
- Melanoma detection from smartphone images
- Lung cancer risk scoring via CT scans
- Early dementia screening (voice & cognitive analysis)
- Smartphone-based otoscope with diagnostic support
- Eye disease detection from retinal imaging
- AI-powered triage and symptom assessment chatbots
- Cervical cytology (Pap smear) automated analysis
Monitoring SaMD (Risk Classes: I – II)
- ECG algorithms for arrhythmia & heart failure prediction
- Continuous glucose monitoring (CGM) data analytics
- Post-operative remote patient monitoring (RPM) platforms
- Wearable-integrated asthma risk alert apps
- Blood pressure tracking with AI risk insights
- Neurological monitoring for epilepsy seizure detection
- Pregnancy monitoring with remote contraction analysis
Therapeutic SaMD / DTx (Risk Classes: I – III)
- CBT-based Digital Therapeutics (DTx) for anxiety & depression
- Behavioral therapy applications for ADHD
- Digital coaching platforms for Type 2 diabetes management
- App-based stroke rehabilitation & motor recovery
- Chronic pain self-management and tracking apps
- Chemotherapy dosage optimization algorithms
- App-controlled neuromodulation devices
Regulatory compliance & standards we follow
IEC 62304
Software lifecycle
for medical device software
IEC 82304-1
Product safety requirements
for standalone health software
ISO 14971
Risk management across
the medical device lifecycle
IEC 62366-1
Usability engineering
for medical software interfaces
IEC 81001-5-1
Security activities across
the health-software lifecycle
FDA 21 CFR 820 (QMSR)
510(k) / De Novo / PMA
FDA quality rule and premarket
pathways for medical software
FDA premarket cybersecurity
(Section 524B)
Mandatory FDA cybersecurity evidence
for connected software, including SBOM
21 CFR Part 11
FDA rule on electronic records
and electronic signatures
EU MDR 2017/745
EU regulation for market access
and safety of medical devices
EU IVDR 2017/746
EU regulation for diagnostic s
oftware that analyzes specimens
UK MDR 2002 / UKCA
UK conformity marking
for medical devices on the GB market
DCB0129 / DCB0160
UK NHS clinical risk
management for health IT
HIPAA / HITECH
US rules for protecting
Protected Health Information
UK GDPR / GDPR / DPA 2018
EU and UK rules for processing health data
HL7 / FHIR
Standards for exchanging
clinical data with EHR systems
DICOM
Standard for storing and
transmitting medical imaging
EU AI Act
EU rules for high-risk AI,
including AI in medical software
FDA PCCP & GMLP
FDA framework for updating
and validating AI/ML models
WCAG 2.2 AA
Accessibility standard
for patient-facing apps
Building healthcare software? Don’t leave compliance for later.
Watch our expert webinar session with Simon Jones, HealthTech Leader with 25+ years of experience, to learn how to avoid expensive rework. Discover how to architect secure data access, align UX with security, and prevent regulatory bottlenecks without sacrificing delivery speed.
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
Rust
C
C++
Kotlin
Bootloader
Linux Kernel
AWS IoT
Arduino
ESP32
STM32
NRF52
Zephyr
LoRaWAN
MQTT
Select Your Plan
Engagement models
Each project has its own unique traits. Flexibility is not an option for us, it’s a basic principle of partnership.
Time and Materials
Ideal for long-term projects with dynamic requirements, this model provides the flexibility to alter scope and workloads as your vision evolves over time.
Managed Team
Seamlessly extend your team with our experts. We provide skilled professionals who integrate with your processes and values while we manage their performance.
Managed Product
Let us be your product co-creator. We take on wide-ranging responsibility, providing the development team and managing the complete lifecycle to build your product together.
Managed Service
Need expert help with a function like design, development, or QA? We provide a fully managed team of specialists to handle that entire process for you.
AI-Enabled Team
The team operates as an AI-Accelerated Pod with built-in pipelines for code review, automated documentation, and test generation. Choose this model when speed to market is your top priority.
Why partner with Yalantis
Proven track record in regulated healthcare
We deliver complex digital health platforms and enterprise-grade software solutions, leveraging 15+ years of experience in safety-critical environments. We understand that for software serving millions of patients, downtime or data breaches are not an option.
Advanced technology & cloud expertise
From memory-safe Rust for high-performance backends to scalable serverless architectures. We ensure 99.99% uptime and solve high-load challenges for multi-tenant SaaS platforms that generalist dev shops cannot handle.
Specialized healthcare engineering teams
Scale your R&D in 2-4 weeks with engineers who already understand clinical workflows, HL7/FHIR standards, and CPT codes. We eliminate the learning curve, ensuring critical domain knowledge remains consistent throughout the lifecycle.
Audit-ready security & compliance
ISO 13485, ISO 9001 and ISO/IEC 27001 certified. We align your product with HIPAA, GDPR, SOC 2, and FDA standards from day one, implementing “Compliance-as-Code” to streamline future audits and market entry.
End-to-end ecosystem synergy
We bridge the gap between fragmented systems. Unifying patient mobile apps, cloud backends, and legacy EHR integrations into a seamless, interoperable healthcare ecosystem that data flows through without friction.
Engineered for business growth
Maximize value by optimizing cloud unit economics and software TCO. We ensure your product makes business sense, focusing on scalable architecture that supports rapid user growth and investor due diligence.
What our clients say
Insights into SaMD consulting and development
Articles
Top 12 Medical Device Development Companies Leading Global Healthcare Innovation
Explore our list of trusted engineering partners with domain expertise, strong software capabilities, and regulatory readiness.
Articles
mHealth Strategy in 2026: How to Turn a Patient Engagement App into a SaMD Product
If your patient app doesn’t deliver outcomes, it won’t get paid or adopted. Here’s how to turn it into a regulated, revenue-generating SaMD product.
Articles
How to Integrate AI/ML in Medical Devices and Systems and Win in Regulated Markets
Learn what you need to prepare, test, document, and deliver when integrating AI/ML into regulated medical devices, with a free compliance guide to help you get it right.
Articles
Medical Device Development: The 6 Phases From Concept to Market
Explore the six phases of medical device development, and find out why the first few weeks decide most of your schedule.
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), De Novo or PMA, CE marking under EU MDR or IVDR, or several markets at once.
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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.
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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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Which regulations and standards apply to SaMD?
It depends on the market and the risk class. In the US, SaMD follows FDA 21 CFR 820 (QMSR), one of the premarket pathways (510(k), De Novo or PMA) and FDA cybersecurity requirements for connected software. In the EU, it is classified under EU MDR Rule 11, or under IVDR when the software analyzes specimens. Across markets, the core standards are IEC 62304 (software lifecycle), ISO 14971 (risk management), IEC 62366-1 (usability), IEC 82304-1 (health software safety) and IEC 81001-5-1 (cybersecurity). Data protection adds HIPAA and GDPR, and NHS deployment adds DCB0129.
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