A mobile robot in a warehouse and a patient monitor in a hospital look nothing alike, but their design teams face the same three pressures: cybersecurity, functional safety, and reliable connectivity. Expectations in all three are rising as devices get smarter and more autonomous, and teams that treat them as late-stage checklists pay for it in redesigns and delayed certification.

The short answer: design for security, safety, and connectivity together from day one. Know which regulations and standards apply to your device, choose your cryptography approach early, plan for the full product lifecycle, and treat wireless reliability as a core requirement. Here is how.

Why are security, safety, and connectivity getting harder to manage?

Connected devices exchange more data, join larger networks, and increasingly sit inside critical infrastructure and healthcare environments. The risks follow:

• Cybersecurity: incidents can cause system downtime, data exposure, operational disruption, and potential safety concerns.
• Safety: unsafe operation of mobile robots, automation equipment, or medical devices can affect human safety, equipment reliability, and operational continuity.
• Connectivity: an unreliable network connection can disrupt operations and reduce productivity.

None of these can be solved in isolation, which is why the strongest designs address all three at once.

Which cybersecurity regulations and standards apply to my device?

It depends on what you build and where you sell it. These are the frameworks you’re most likely to meet:

• Cyber Resilience Act (CRA): a European regulation covering products with digital elements, including vulnerability handling, security updates, and lifecycle protection.
• Medical Device Regulation (MDR): European safety and performance requirements for medical devices, including cybersecurity for connected equipment.
• IEC 62443: an international series for industrial automation and control systems, covering secure product development, component certification, and system-level security. NXP has achieved IEC 62443-4-1 certification for its development process.
• Federal Information Security Modernization Act (FISMA): a U.S. federal framework for protecting information systems through security controls, risk management, and continuous monitoring.

The common thread is that regulators increasingly expect security across the whole lifecycle, not just at launch.

Where does FIPS 140-3 fit?

FIPS 140-3 is a U.S. federal standard for the security of cryptographic modules, based on ISO/IEC 19790 and ISO/IEC 24759. It matters most when you sell into federal customers. VA hospitals, for example, apply the requirement to Wi-Fi: VA Directive 6550 prohibits procurement of 802.11 wireless systems that aren’t FIPS 140-2 compliant. FIPS 140-3 is now the standard to design around, because NIST moved every remaining FIPS 140-2 certificate to its Historical List in September 2026 (see NIST’s FIPS 140-3 Transition Effort page for details).

Teams generally take one of two paths.

1. FIPS validated product: the product itself is validated against FIPS 140-3.

2. FIPS Inside product: the product uses FIPS 140-3 validated modules to provide its security services. This path requires care: you must make sure non-validated modules aren’t used for security services alongside validated ones.

Either way, validation applies to a defined cryptographic module, so confirm that the module covers the security services your device relies on.

How do functional safety standards apply to industrial and medical devices?

Functional safety is about how a system behaves when something fails. IEC 61508 provides a risk-based framework for developing safety-related electronic systems, widely used in industrial automation. IEC 60601-1 addresses the basic safety and essential performance of medical electrical equipment.

Platform features can help. The NXP i.MX 95 integrates a dedicated Cortex-M33 safety domain, and features such as ECC-protected memory can help manage faults. NXP’s SafeAssure program provides safety documentation, software, and expert support. But platform features don’t establish compliance on their own. Manufacturers remain responsible for system integration, risk management, and verifying that the complete device meets the applicable requirements.

How do you keep devices secure after launch?

Medical and industrial devices often stay in service for many years, so security has to continue after shipment. Plan for three things:

• Long-term software updates: NXP provides long-term support releases for the i.MX Yocto Project with regular security patches and vulnerability remediation.
• A software bill of materials (SBOM): so you know exactly which components are inside your product.
• Vulnerability monitoring and disclosure: standards such as ISO/IEC 30111 and ISO/IEC 29147 describe how to handle and disclose vulnerabilities. Silex offers AMC (Absolutely Must Connect) Protect, a service that includes SBOM management, vulnerability monitoring, and reporting.

Why does wireless reliability matter as much as security?

A secure, safe device still has to stay connected, whether it’s a robot crossing a warehouse or a medical device moving between hospital access points.

Two developments help. The 6 GHz Wi-Fi band moves devices off the crowded 2.4 GHz band, which reduces congestion and improves coexistence with Bluetooth, Zigbee, and Thread. And careful integration makes the difference in practice: Silex applies its Wi-Fi validation criteria to optimize NXP’s Wi-Fi reference driver for roaming performance and enterprise security, supports regional radio regulatory requirements, and helps port drivers to customers’ preferred platforms. Silex is also working toward validating Wi-Fi modules against FIPS 140-3.

What’s next at the edge?

Edge AI lets devices analyze data where it’s generated, in real time, with less reliance on the cloud. The i.MX 95 integrates an NPU for on-chip AI processing, and compatible platforms can add an Ara240 accelerator module over an M.2 Key-M interface for heavier workloads. UWB positioning is available through NXP’s partner ecosystem.

From platform to product

A capable processor is only the start. NXP brings processing, security, safety, and connectivity technologies, and Silex adds embedded system design, wireless integration, software enablement, manufacturing, and long-term lifecycle support. Together, they help teams move from platform selection to production.

A starting checklist

1. Map your requirements: which regulations and standards apply to your device and your customers?
2. Choose your cryptography approach early: FIPS validated product or FIPS Inside design.
3. Plan safety alongside security, and bring in IEC 61508 and IEC 60601-1 before the architecture is locked.
4. Plan the lifecycle: updates, SBOM, and vulnerability monitoring.
5. Treat wireless as part of the design: roaming, enterprise security, and regional radio compliance.

FAQ

Do medical and industrial devices follow the same standards?
They overlap but aren’t identical. Both face cybersecurity, safety, and connectivity requirements, but medical devices are shaped by rules such as MDR and IEC 60601-1, while industrial equipment often looks to IEC 62443 and IEC 61508.

Is FIPS 140-3 required for medical devices? No single rule requires it for every device. It becomes a practical requirement when you sell to federal healthcare customers: VA Directive 6550, for instance, prohibits procurement of 802.11 wireless systems that aren’t FIPS 140-2 compliant. FDA’s premarket cybersecurity guidance also expects manufacturers to justify the cryptography they choose, without prescribing specific algorithms, which validated modules can help support (see FDA Premarket Cybersecurity Guidance and the VA Directive 6550).

What is an SBOM, and why does it matter?
A software bill of materials lists the software components inside your product. It gives you visibility for vulnerability management, which regulations such as the CRA make increasingly important.

Does a safety-ready platform make my device compliant?
No. Platform safety features can support your risk controls and safety assessments, but the manufacturer remains responsible for verifying that the complete device meets its requirements.