EU Compliance Integration Consulting

They play completely different roles. IEC 62443 (parts 4-1 and 4-2) is a primary CRA Harmonised Standard — compliance creates a presumption of conformity enabling CE marking. ISO 26262 is a vehicle functional safety standard addressing random electronic failures; it is not a CRA Harmonised Standard and cannot satisfy CRA alone. Automotive ECU suppliers need both: ISO 26262 for functional safety and IEC 62443 for cybersecurity, integrated through Safety-Security analysis to enable CE marking.

Winners Consulting's Safety-Security integration pathway saves 30–40% in costs. ISO 26262 HARA results feed directly into IEC 62443 TARA, identifying which attacks can trigger functional safety hazards and producing a Safety-Security interface list satisfying both standards' audit requirements. The unified documentation architecture is built once to support both ISO 26262 certification bodies and CRA Notified Bodies.

EU CRA entered into force in December 2024 with a 36-month transition. From September 2027, all connected products exported to the EU must meet CRA requirements and bear CE marking or face a market ban. Taiwan exporters should initiate compliance projects in 2025–2026 to allow time for testing, verification, and Notified Body review.

IEC 62443-4-2 maps to: no known exploitable vulnerabilities (CR 7.2), secure-by-default configuration (CR 3.1), authentication and access control (CR 1.x), data encryption (CR 4.1), security update mechanisms (CR 7.3). IEC 62443-4-1 maps to SBOM obligations (SM-9) and secure development process requirements. IEC 62443-2-3 maps to the 72-hour vulnerability disclosure mechanism. Conformance creates presumption of conformity with corresponding CRA requirements.

Higher ASIL ratings with network attack exposure require higher IEC 62443 Security Levels. General principle: ASIL C-D functions recommend SL 3 or above; ASIL A-B recommend SL 2. Winners Consulting maps ASIL decomposition results directly to IEC 62443-4-2 Component Requirements (CR), ensuring control intensity aligns precisely with functional safety needs.

Class I (third-party review required): operating systems, routers, industrial controllers, mobile device management software, automotive ECUs. Class II (strict third-party certification): industrial firewalls, HSMs, smart meters, automotive gateways, security chips. Class I/II products cannot self-assess and must engage a Notified Body. Winners Consulting provides product classification diagnosis and Notified Body selection support.

Yes, both apply simultaneously to connected AI systems (e.g., automotive AI driving assistance, factory AI predictive maintenance). EU AI Act Annex IV technical documentation and CRA technical documentation share significant structural overlap — Winners Consulting designs a unified architecture built once to satisfy both regulatory audits.

Most consultants specialize in only one standard, forcing clients to engage multiple firms and leaving the Safety-Security integration interface unmanaged. Winners Consulting, backed by an academic partnership with National Taiwan University of Science and Technology's cybersecurity center, provides VP/Director-level consultants proficient in both functional safety and cybersecurity, executing integrated analysis, designing unified documentation, and providing full accompaniment through CE marking with 90-day post-certification tracking.