Building an IoT product for a regulated industry? Our IoT compliance services help you navigate certification and security standards, from SOC2 to FedRAMP, including IEC 62443, ISO 13485, HIPAA, and ATEX, with support for hardware, firmware, cloud, and mobile.
IoT Compliance Support for Regulated Devices and Systems
Common IoT regulatory compliance challenges we address
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.
Insecure firmware and devices
Vulnerable IoT devices become entry points for cyberattacks. Our secure-by-design approach to IoT device compliance builds protection into every layer of your system to mitigate the risk of breaches, fines, and recalls.
Lack of domain expertise
Specialized IoT regulatory compliance requirements (HIPAA, ATEX, IECEx, etc.) demand a deep understanding of niche regulatory frameworks. We bring years of experience with industry-specific standards.
Dealing with legacy systems
Older IoT infrastructure often lacks the security controls required by current standards. We develop strategies to achieve IoT device compliance for legacy systems without disrupting operations.
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.
Compliance testing
Insufficient test coverage results in missing critical vulnerabilities and misalignment with the standards. As part of our IoT compliance services, we provide comprehensive compliance checks, ensuring your IoT devices pass certification on the first attempt.
Our IoT compliance services
Full-cycle support
We provide IoT compliance support throughout the full cycle, from initial concept through production deployment, with compliance requirements integrated throughout the development flow.
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.
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.
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.
ATEX and IECEx certification readiness
Receive guidance on equipment and documentation for hazardous environments, including IECEx and ATEX certification for IoT devices. We’ll take care of all documentation and procedures.
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.
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.
Pre-certification testing
Test systems under simulated failure and penetration conditions before submitting for certification. We run compliance checks in controlled environments to identify and resolve issues early, so your product passes certification on the first attempt.
Explore more
Medical device compliance framework
Get our comprehensive ISO 13485 & FDA compliance guide with practical certification steps for connected healthcare devices and medical software.
IoT device compliance & certification for various industries
IEC 62443 EN/IEC 60079 series
ISO 27001/27019 ISO 13485 ISO 17363–17365 ISO 28000 CAN (ISO 11898) ISO 26262 ISO 11898
ISA-95
OPC UA
SOC2
FedRAMP
Directive 2014/53/EU
ATEX (Directive 2014/34/EU)
IECEx
UL 913
FM 3610
CSA C22.2
HIPAA
GDPR
MDR / FDA Regulations
ISO/IEC 80001
GS1 EPC/RFID Standards
CISA / NIST Guidelines
Digital Transport and Logistics Forum (DTLF)
ISO/SAE 21434
UN Regulation No. 155 (CSMS) UN Regulation No. 156 (SUMS) WP.29 (UNECE)
SAE J3061
OCPP
CCPA / CPRA
ETSI EN 303 645
SOC 2
EU CRA
EU Machinery Regulation
Compliance-first development process
Compliance audit / Gap analysis
We start by evaluating your current systems and processes against the regulatory standards that apply to your product. This helps us identify compliance gaps and prioritize what needs to be done before development begins.
Design
Based on the findings, we translate compliance requirements into system architecture, defining security controls, data flows, and documentation structure so every component is ready for certification.
Develop
From there, our team writes compliance-ready code with regulatory standards built into every module, applying secure coding practices that align with your target certifications.
Validate
Before submission, we run pre-certification tests to verify that everything meets regulatory requirements and catch any remaining issues. At this stage, we also prepare all the documentation for regulatory bodies.
Deploy and maintain
Once certified, we stay with you, providing long-term support, update management, and compliance monitoring to keep your systems certified as regulations evolve.
Technologies we work with
Rust
C
C++
Kotlin
Bootloader
Linux Kernel
AWS IoT
Arduino
ESP32
STM32
NRF52
Zephyr
LoRaWAN
MQTT
Secure edge computing
BLE
cellular
Embedded & SCADA integration
AWS
Azure
AI/ML-powered security analytics
OTA update systems with rollback support
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 IoT security compliance: our team builds end-to-end platforms as an 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.
What our clients say
IoT compliance insights
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HIPAA Compliance Checklist for Healthcare Software Development
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How to Integrate AI/ML in Medical Devices and Systems and Win in Regulated Markets
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FAQ
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What is IoT compliance?
IoT compliance means your connected devices and systems meet the regulatory standards required for your industry and target market. It covers certifications, security controls, and documentation that regulators and auditors expect before your product can go to market.
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What are the key IoT compliance frameworks and standards?
It depends on your industry. Healthcare teams deal with HIPAA, ISO 13485, and FDA regulations. Industrial and manufacturing products typically fall under IEC 62443 and ATEX. Automotive has ISO 26262 and UN Regulation 155/156. We work across all of these and more, so wherever you operate, we know the rulebook.
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What is the difference between IoT security and IoT compliance?
Security is about protecting your devices from threats. Compliance is about proving to regulators and auditors that you have done so, following their specific frameworks. In practice, the two go hand in hand. Good security makes compliance easier, and compliance requirements push you toward better security. We handle both together.
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What IoT compliance services does Yalantis provide?
We cover secure architecture design, firmware hardening and secure OTA updates, risk analysis and threat modeling, ATEX and IECEx certification readiness, healthcare IoT security compliance, pre-certification testing, and automated compliance-ready IoT platforms. We also provide full-cycle IoT compliance support from concept through deployment and beyond.
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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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How do you ensure IoT device compliance across multiple standards?
We map all applicable requirements at the architecture stage, before a single line of code is written. This way, IoT device compliance across overlapping frameworks gets built into the product rather than bolted on later, which saves significant time and cost down the road.
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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.
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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.
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