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Product cyber & CRA

Secure-by-design compliance for connected products

EU Cyber Resilience Act, RED cybersecurity, IEC 62443, ETSI EN 303 645, and UL 2900 — threat modeling, SBOM, and evidence for market access.

Product cybersecurity compliance for connected devices

What this engagement covers

Connected products increasingly need cybersecurity evidence alongside CE/FCC. We map applicable regimes (CRA, RED Delegated Regulation, IEC 62443, consumer IoT baselines), build a security requirements and testing plan, and structure SBOM / vulnerability-handling documentation so engineering and compliance share one story.

Best fit for

  • IoT / IIoT OEMs selling into the EU under CRA / RED cyber
  • Industrial control and OT device makers targeting IEC 62443
  • Consumer connected products needing ETSI EN 303 645 / NISTIR baselines
  • Teams preparing security evidence for retailers, utilities, or notified bodies

What's included

  • Regulatory applicability map (CRA, RED cyber, sector schemes)
  • Threat model & security objectives workshop
  • Security requirements specification aligned to standards
  • SBOM / vulnerability disclosure / update policy structure
  • Penetration / vulnerability test plan coordination
  • Technical documentation package for CE / customer audits

Product types we support

Scope changes by product architecture — these are the classes we regularly take through this pathway.

Consumer IoT

Cameras, hubs, smart appliances, wearables

Industrial gateways & PLCs

OT edge devices, protocol converters

Medical connected devices

Cyber overlays on 60601 / FDA expectations

Energy / EVSE / metering

Grid-adjacent and utility cybersecurity requirements

Radio equipment under RED

Internet-connectable radio products

Cloud-connected industrial sensors

Firmware update and identity/auth stacks

Technical categories

Control themes we document

Unique identity & authSecure updateEncrypted communicationsVulnerability disclosureSBOMHardening / interface minimizationLogging & support period

Evidence artifacts

Threat modelSecurity requirementsArchitecture / trust boundariesTest reportsSBOM (SPDX/CycloneDX)PSIRT processUser security documentation

Regions & schemes

Market access is scheme-specific. We map filings and evidence to the regions you actually sell into.

European Union

  • •Cyber Resilience Act (CRA)
  • •RED Delegated Regulation (EU) 2022/30
  • •EN 18031 series (as applicable)
  • •Notified Body pathways when required

United States

  • •FDA premarket cyber (medical)
  • •NISTIR 8259 / customer baselines
  • •UL 2900 when pursued
  • •State IoT labeling laws as applicable

Industrial global

  • •IEC 62443 certifications / assessments
  • •ISASecure / IECEE schemes where used

UK / others

  • •PSTI Act (consumer connectable)
  • •ETSI EN 303 645 adoption

Directives & regulations

EU Cyber Resilience Act

Horizontal cyber requirements for products with digital elements

RED Delegated Regulation (EU) 2022/30

Cyber/privacy essential requirements for certain radio equipment

UK PSTI Act 2022

Consumer connectable product security

NIS2 (organizational interface)

Often drives customer security questionnaires to OEMs

Key standards

StandardFocus
ETSI EN 303 645Cybersecurity for consumer IoT
EN 18031-1/-2/-3Common security requirements for radio equipment (RED)
IEC 62443-4-1 / 4-2Secure product development & component requirements
IEC 62443-3-3System security requirements and security levels
UL 2900-1 / -2-xSoftware cybersecurity for network-connectable products
NISTIR 8259 / 8259A/BIoT device cybersecurity capability core baseline
ISO/IEC 27034 / 29147 / 30111Application security & vulnerability handling references

Marks & program keywords

CRARED CyberIEC 62443EN 303 645UL 2900NISTIR 8259

How we work

One clear path from classification to market-ready evidence.

Step 1

Scope

Product class, connectivity, and applicable cyber regimes

Step 2

Require

Security objectives, controls, and update strategy

Step 3

Verify

Testing, SBOM, and vulnerability process evidence

Step 4

Declare

Docs ready for CRA/RED/customer assessment

Engineering notes

CRA timelines and product categories determine whether you need self-assessment or third-party involvement — we classify early so roadmap and BOM decisions are realistic.

Radio CE without cyber evidence is increasingly incomplete for internet-connectable devices; we align RED cyber with your EMC/RF program.

Clear cyber regime map

Assessor-ready evidence

Fewer late security blockers

Ready to scope Cybersecurity?

30-minute consultation with Hazloc Labs — bring your product type, target markets, and any existing reports.

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