IoT Compliance Support

IoT compliance support for regulated devices and systems

Building an IoT product for a regulated industry? We help you navigate certification and security standards, from SOC2 to FedRAMP, with support for hardware, firmware, cloud, and mobile.

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Whom we help

Medical IoT Device Manufacturers

Medical IoT device manufacturers

We help businesses comply with HIPAA, MDR, FDA, and ISO 13485 for medical IoT to ensure safety.

Medical IoT Device Manufacturers
Industrial Companies

Industrial companies

We help companies meet ATEX, IECEx, UL 913, and IEC 62443 IoT compliance, providing security and certification support.

Industrial Companies
Automotive Companies

Automotive companies

We help businesses meet ISO/SAE 21434, ISO 11898, ISO 26262, UN 155/156 by implementing secure communication protocols.

Automotive Companies
Logistics Providers

Logistics providers

We support providers with GS1 EPC/RFID, ISO 28000, and GDPR IoT frameworks, ensuring custody integrity and compliance worldwide.

Logistics Providers
Smart City and Infrastructure Providers

Smart city and infrastructure providers

We help companies meet GDPR, NIST, and IEC by building secure, compliant IoT systems for municipalities and infrastructure.

Smart City and Infrastructure Providers
European Companies from Various Domains

European companies from various domains

We help businesses comply with the Radio Equipment Directive 2014/53/EU (RED), preparing fully compliant, market-ready devices.

European Companies from Various Domains

Common IoT regulatory compliance challenges we address

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    Complex and fragmented certification processes

    Multiple standards bodies, overlapping requirements, and unclear documentation create bottlenecks that can push launch dates by months or years. We streamline the certification process to avoid this.

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    Insecure firmware and devices

    Vulnerable IoT devices become entry points for cyberattacks. Our secure-by-design approach builds protection into every layer of your system to mitigate the risk of breaches, fines, and recalls.

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    Lack of domain expertise

    Specialized IoT compliance requirements (HIPAA, ATEX, IECEx, etc.) demand a deep understanding of niche regulatory frameworks. We bring years of experience with industry-specific standards.

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    Dealing with legacy systems

    Older IoT infrastructure often lacks the security controls required by current standards. We develop strategies to fix these gaps, bringing legacy systems into the game without disrupting operations.

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    Manual compliance tracking

    Spreadsheet-based management results in inefficiency, audit stress, and missed updates. Our automated reporting systems provide real-time visibility into compliance status and alert you to required actions.

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    Compliance testing

    Insufficient test coverage results in missing critical vulnerabilities and misalignment with the standards. We provide comprehensive compliance checks, ensuring your IoT devices pass certification on the first attempt.

Our comprehensive IoT integration services

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Full-cycle support

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Secure architecture design

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Risk analysis and threat modeling

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Firmware hardening and secure OTA

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ATEX and IECEx certification readiness

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Healthcare IoT security compliance

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Automated IoT compliance platform

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Regulatory sandbox environments

Full-cycle support

We handle complete compliance achievement for devices and software from initial concept through production deployment, with compliance requirements integrated throughout the development flow.

Full-Cycle Support

Secure architecture design

We design IoT architectures with compliance embedded at the foundation. Your software is built to meet IEC 62443, ISO 13485, and ISO 27001 IoT security requirements from day one.

Secure Architecture Design

Risk analysis and threat modeling

Identify compliance gaps in architecture and firmware early. We map potential attack vectors and blind spots to focus on as part of an IoT risk management service.

Risk Analysis and Threat Modeling

Firmware hardening and secure OTA

Encrypt updates, ensure traceability and rollback in case of failure to guarantee bulletproof updates. We can achieve this through cryptographic verification, audit trails, and fail-safe recovery mechanisms.

Firmware Hardening and Secure OTA

ATEX and IECEx certification readiness

Receive guidance on equipment and documentation for hazardous environments, such as IECEx and ATEX certification IoT. We’ll take care of all documentation and procedures.

ATEX and IECEx Certification Readiness

Healthcare IoT security compliance

Grant HIPAA, ISO 80001, and FDA readiness for med tech platforms. We ensure your software meets device security and clinical safety standards for successful market entry.

Healthcare IoT Security Compliance

Automated IoT compliance platform

Facilitate operations with push‑button IoT reporting and audits, security logs, and regulatory dashboards. We’ll set up monitoring for ongoing adherence to regulatory requirements.

Automated IoT Compliance Platform

Regulatory sandbox environments

Test systems under simulated failure and penetration conditions. We’ll create controlled environments that simulate compliance scenarios to prepare to withstand real attacks.

Regulatory Sandbox Environments
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Full-cycle support

We handle complete compliance achievement for devices and software from initial concept through production deployment, with compliance requirements integrated throughout the development flow.

Full-Cycle Support
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Secure architecture design

We design IoT architectures with compliance embedded at the foundation. Your software is built to meet IEC 62443, ISO 13485, and ISO 27001 IoT security requirements from day one.

Secure Architecture Design
icon

Risk analysis and threat modeling

Identify compliance gaps in architecture and firmware early. We map potential attack vectors and blind spots to focus on as part of an IoT risk management service.

Risk Analysis and Threat Modeling
icon

Firmware hardening and secure OTA

Encrypt updates, ensure traceability and rollback in case of failure to guarantee bulletproof updates. We can achieve this through cryptographic verification, audit trails, and fail-safe recovery mechanisms.

Firmware Hardening and Secure OTA
icon

ATEX and IECEx certification readiness

Receive guidance on equipment and documentation for hazardous environments, such as IECEx and ATEX certification IoT. We’ll take care of all documentation and procedures.

ATEX and IECEx Certification Readiness
icon

Healthcare IoT security compliance

Grant HIPAA, ISO 80001, and FDA readiness for med tech platforms. We ensure your software meets device security and clinical safety standards for successful market entry.

Healthcare IoT Security Compliance
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Automated IoT compliance platform

Facilitate operations with push‑button IoT reporting and audits, security logs, and regulatory dashboards. We’ll set up monitoring for ongoing adherence to regulatory requirements.

Automated IoT Compliance Platform
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Regulatory sandbox environments

Test systems under simulated failure and penetration conditions. We’ll create controlled environments that simulate compliance scenarios to prepare to withstand real attacks.

Regulatory Sandbox Environments
  • icon

    Full-cycle support

    We handle complete compliance achievement for devices and software from initial concept through production deployment, with compliance requirements integrated throughout the development flow.

    Full-Cycle Support
  • icon

    Secure architecture design

    We design IoT architectures with compliance embedded at the foundation. Your software is built to meet IEC 62443, ISO 13485, and ISO 27001 IoT security requirements from day one.

    Secure Architecture Design
  • icon

    Risk analysis and threat modeling

    Identify compliance gaps in architecture and firmware early. We map potential attack vectors and blind spots to focus on as part of an IoT risk management service.

    Risk Analysis and Threat Modeling
  • icon

    Firmware hardening and secure OTA

    Encrypt updates, ensure traceability and rollback in case of failure to guarantee bulletproof updates. We can achieve this through cryptographic verification, audit trails, and fail-safe recovery mechanisms.

    Firmware Hardening and Secure OTA
  • icon

    ATEX and IECEx certification readiness

    Receive guidance on equipment and documentation for hazardous environments, such as IECEx and ATEX certification IoT. We’ll take care of all documentation and procedures.

    ATEX and IECEx Certification Readiness
  • icon

    Healthcare IoT security compliance

    Grant HIPAA, ISO 80001, and FDA readiness for med tech platforms. We ensure your software meets device security and clinical safety standards for successful market entry.

    Healthcare IoT Security Compliance
  • icon

    Automated IoT compliance platform

    Facilitate operations with push‑button IoT reporting and audits, security logs, and regulatory dashboards. We’ll set up monitoring for ongoing adherence to regulatory requirements.

    Automated IoT Compliance Platform
  • Icon

    Regulatory sandbox environments

    Test systems under simulated failure and penetration conditions. We’ll create controlled environments that simulate compliance scenarios to prepare to withstand real attacks.

    Regulatory Sandbox Environments

IoT device certification for various industries

General security standards

  • IEC 62443 logo

    IEC 62443

  • ISO 27001/27019

    ISO 27001/27019

  • ISA-95 logo

    ISA-95

  • OPC UA logo

    OPC UA

  • SOC2

    SOC2

  • FedRAMP

    FedRAMP

  • Directive 2014/53/EU

    Directive 2014/53/EU

Hazardous Environment Compliance

  • ATEX logo

    ATEX (Directive 2014/34/EU)

  • IECEx logo

    IECEx

  • UL 913 logo

    UL 913

  • FM 3610 logo

    FM 3610

  • CSA C22.2 logo

    CSA C22.2

  • EN/IEC 60079 logo

    EN/IEC 60079 series

Healthcare

  • HIPAA

    HIPAA

  • GDPR logo

    GDPR

  • MDR / FDA Regulations

    MDR / FDA Regulations

  • ISO 13485

    ISO 13485

  • ISO/IEC 80001

    ISO/IEC 80001

Logistics

  • GS1 EPC/RFID logo

    GS1 EPC/RFID Standards

  • ISO logo

    ISO 17363–17365

  • ISO logo

    ISO 28000

  • CISA / NIST logo

    CISA / NIST Guidelines

  • DTLF logo

    Digital Transport and Logistics Forum (DTLF)

Automotive

  • ISO logo

    CAN (ISO 11898)

  • ISO/SAE 21434 logo

    ISO/SAE 21434

  • No. 155 (CSMS) logo

    UN Regulation No. 155 (CSMS)

  • UN Regulation No. 156 (SUMS) logo

    UN Regulation No. 156 (SUMS)

  • SAE J3061 logo

    SAE J3061

  • ISO logo

    ISO 26262

  • ISO logo

    ISO 11898

  • WP.29 (UNECE) logo

    WP.29 (UNECE)

  • OCPP logo

    OCPP

IoT compliance use cases

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HIPAA-compliant RPM platform

Enabled end-to-end encryption, data governance, and HIPAA documentation workflows for a remote patient monitoring solution.

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IEC 62443-compliant IIoT gateway

Hardened firmware and secure communication channels for a manufacturing automation system.

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ATEX-certified sensor suite

Supported embedded development and documentation for a predictive maintenance solution used in explosive zones.

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HIPAA-compliant RPM platform

Enabled end-to-end encryption, data governance, and HIPAA documentation workflows for a remote patient monitoring solution.

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IEC 62443-compliant IIoT gateway

Hardened firmware and secure communication channels for a manufacturing automation system.

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ATEX-certified sensor suite

Supported embedded development and documentation for a predictive maintenance solution used in explosive zones.

Testimonials from our clients

“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.”

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

“Working with Yalantis is really good and we’re satisfied with the partnership so far. They helped us with whole aspects of development, like front-end, back-end, DevOps, and product management. They are very good when it comes to communication and organizing. They meet our deadlines all the time, plan everything carefully. Also, the team writes high-level code. Overall, I’m very impressed with Yalantis communication and how they manage everything. Their quality is very high.”

Gonen Krak

CTO & Co-founder of AironWorks

“Yalantis played a crucial role in accelerating our SDK development. They ensured seamless integration with our existing back-end, keeping product quality high and delivering on schedule. One of the biggest advantages of workers in Yalantis is that they’ve become the knowledge keepers of our SDK, ensuring continuity, scalability, and smooth onboarding for the new members. I would definitely recommend Yalantis to any company looking for a trusted development partner.”

Oleg Lesov

CEO at Reteno

Technologies we work with

  • Rust logo

    Rust

  • C logo

    C

  • C++

    C++

  • Kotlin logo

    Kotlin

  • Bootloader logo

    Bootloader

  • Linux Kernel logo

    Linux Kernel

  • AWS IoT logo

    AWS IoT

  • Arduino logo

    Arduino

  • ESP32 logo

    ESP32

  • STM32 logo

    STM32

  • NRF52 logo

    NRF52

  • Zephyr logo

    Zephyr

  • LoRaWAN logo

    LoRaWAN

  • MQTT logo

    MQTT

  • Edge Computing logo

    Secure edge computing

  • BLE logo

    BLE

  • cellular logo

    cellular

  • Embedded & SCADA integration

    Embedded & SCADA integration

  • AWS logo

    AWS

  • Azure logo

    Azure

  • AI/ML-powered security analytics

    AI/ML-powered security analytics

  • Secure OTA Updates logo

    OTA update systems with rollback support

Compliance-first development process

  • point 1

    Design

    Mapping your specific compliance requirements to system architecture. Identifying security controls and documentation upfront to lay a strong, secure foundation.

  • point 2

    Develop

    Writing compliance-ready code with regulatory standards built into every module. Applying secure coding practices that align with certifications and regulations.

  • point 3

    Validate

    Conducting pre-certification tests to simulate real certification scenarios and spot issues that need to be resolved. Preparing all required documentation for regulatory bodies.

  • Point 4

    Deploy and Maintain

    Providing long-term support, update management, and IoT security audit tools. Ensuring your systems stay certified and adapt to regulations.

Why work with Yalantis

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Expertise across frameworks

You can entrust the certification-related work to our team, regardless of the standard – IEC 62443, HIPAA, ATEX, GDPR, ISO 26262 connected car compliance, or others.

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Custom IoT and compliance engineering

Your firmware, hardware, and cloud will be in sync in terms of performance and compliance: our team builds end-to-end platforms integrated system from the start.

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Certification partner network

You don’t need to research and guess what each organization expects from your software. We work with notified bodies and auditors to guide you through the requirements.

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Security-first mindset

Forget about securing IoT devices as an add-on service. Risk modeling, encryption, and cyber threat mitigation built into every project.

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Scalable engagement

Get exactly what your project requires now. From PoC to full compliance lifecycle outsourcing, we scale our involvement to fit your needs and current challenges.

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Long-term compliance care

Our work doesn’t end at certification. We support you in maintaining compliance as standards evolve.

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Expertise across frameworks

You can entrust the certification-related work to our team, regardless of the standard – IEC 62443, HIPAA, ATEX, GDPR, ISO 26262 connected car compliance, or others.

icon

Custom IoT and compliance engineering

Your firmware, hardware, and cloud will be in sync in terms of performance and compliance: our team builds end-to-end platforms integrated system from the start.

icon

Certification partner network

You don’t need to research and guess what each organization expects from your software. We work with notified bodies and auditors to guide you through the requirements.

icon

Security-first mindset

Forget about securing IoT devices as an add-on service. Risk modeling, encryption, and cyber threat mitigation built into every project.

icon

Scalable engagement

Get exactly what your project requires now. From PoC to full compliance lifecycle outsourcing, we scale our involvement to fit your needs and current challenges.

icon

Long-term compliance care

Our work doesn’t end at certification. We support you in maintaining compliance as standards evolve.

FAQ

Can Yalantis help us pass ATEX or UL 913 IoT device certification?

Yes, we assist in design, documentation, and certification preparation for hazardous-area equipment. Our team has experience with UL 913, ATEX, and IECEx IoT compliance frameworks and is ready to ensure safety and performance standards.

Do you provide GDPR or HIPAA-compliant cloud development?

Absolutely. We specialize in compliant cloud architecture, data encryption, and governance. Your software will meet both GDPR and HIPAA IoT compliance requirements, ensuring it is always ready to pass an IoT device security certification.

How early should we bring in your compliance experts?

As early as possible—ideally during the concept and architecture stages to save time and avoid costly rework. Preparing IoT for regulatory compliance early allows us to embed the requirements into the foundation of your system, reducing the certification timelines.

Contact us

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    Nick Orlov photo

    Nick Orlov

    Engagement Manager

    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!