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.
Whom we help
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
We handle complete compliance achievement for devices and software from initial concept through production deployment, with compliance requirements integrated throughout the development flow.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
IoT device certification for various industries
General security standards
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IEC 62443
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ISO 27001/27019
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ISA-95
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OPC UA
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SOC2
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FedRAMP
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Directive 2014/53/EU
Hazardous Environment Compliance
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ATEX (Directive 2014/34/EU)
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IECEx
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UL 913
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FM 3610
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CSA C22.2
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EN/IEC 60079 series
Healthcare
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HIPAA
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GDPR
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MDR / FDA Regulations
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ISO 13485
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ISO/IEC 80001
Logistics
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GS1 EPC/RFID Standards
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ISO 17363–17365
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ISO 28000
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CISA / NIST Guidelines
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Digital Transport and Logistics Forum (DTLF)
Automotive
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CAN (ISO 11898)
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ISO/SAE 21434
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UN Regulation No. 155 (CSMS)
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UN Regulation No. 156 (SUMS)
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SAE J3061
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ISO 26262
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ISO 11898
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WP.29 (UNECE)
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OCPP
IoT compliance use cases
HIPAA-compliant RPM platform
Enabled end-to-end encryption, data governance, and HIPAA documentation workflows for a remote patient monitoring solution.
IEC 62443-compliant IIoT gateway
Hardened firmware and secure communication channels for a manufacturing automation system.
ATEX-certified sensor suite
Supported embedded development and documentation for a predictive maintenance solution used in explosive zones.
Testimonials from our clients
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
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Secure edge computing
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BLE
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cellular
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Embedded & SCADA integration
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AWS
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Azure
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AI/ML-powered security analytics
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OTA update systems with rollback support
Compliance-first development process
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Design
Mapping your specific compliance requirements to system architecture. Identifying security controls and documentation upfront to lay a strong, secure foundation.
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Develop
Writing compliance-ready code with regulatory standards built into every module. Applying secure coding practices that align with certifications and regulations.
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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.
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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
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.
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.
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.
Security-first mindset
Forget about securing IoT devices as an add-on service. Risk modeling, encryption, and cyber threat mitigation built into every project.
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.
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.
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Engagement Manager
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!