02 · Functional & Cyber Security

Functional Safety & Cybersecurity

Assessment, audit, training, inspection and certification — ISO 26262 · ISO 21448 · IEC 61508 · IEC 62061 · ISO 13849 · UN R155 / R156 · ISO/IEC 27001.

Division Overview

European front office for Wanve Group's Cyber & Functional Safety Division

Wanve Sweden AB serves as the European interface of the Wanve Group Cyber & Functional Safety Division. The division delivers assessment, audit, technical training, inspection, R&D testing and certification across automotive, off-highway, industrial control, rail transit, medical, energy storage, IoT and information systems — backed by EU Notified Body status (NB 2406, ENAVE, Italy) and full CNAS / CMA accreditation in China.

Two Pillars

Functional Safety and Cybersecurity, run as one programme

Functional Safety

Six business groups across automotive, off-highway, industrial process, rail, medical and energy storage. Coverage from concept-phase HARA through hardware metrics, V&V and confirmation review.

Standards

ISO 26262 · ISO 21448 (SOTIF) · ISO 13849 · IEC 61508 · IEC 62061 · IEC 61511 · EN 50128 · IEC 60601 · IEC 62304 · IEC 61513 · IEC 63065 · UL 1973 · IEC 62619 · IEC 62933

Cybersecurity

Five business groups across automotive, industrial control, medical, IoT and information systems. End-to-end TARA, CSMS / SUMS, secure SDLC, pen-testing and type-approval support.

Standards

ISO/SAE 21434 · UN R155 · UN R156 · IEC 62443 · ISO/IEC 27001 · ISO/IEC 27701 · ISO 27799 · IEC 81001-5-1 · NIST SP 800 · UL 2900 · MDCG 2019-16 · EU 2017/745 · EU 2017/746 · EU 2016/679

FuSa · Business Groups

Six functional-safety verticals

FS-01
Automotive Electronics

ISO 26262 · ISO 21448 (SOTIF)

FS-02
Off-Highway Machinery

ISO 13849 · ISO 25119

FS-03
Industrial Process & Automation

IEC 61508 · IEC 62061 · IEC 61511

FS-04
Rail Transit

EN 50126 · EN 50128 · EN 50129

FS-05
Medical Devices

IEC 60601 · IEC 62304 · ISO 14971

FS-06
Energy & Battery Storage

IEC 61513 · IEC 63065 · UL 1973 · IEC 62619 · IEC 62933

FuSa · Services

From HARA to product certification

01
Concept-phase gap analysis

HARA, item definition, ASIL decomposition and safety-goal derivation aligned to ISO 26262 Part 3 and SOTIF triggering-condition analysis.

02
Safety case & work-product audit

Independent confirmation reviews and functional-safety audits across system, hardware and software development phases (ISO 26262 Parts 4-6).

03
Process & SMS build-up

Establish a Safety Management System aligned with ISO 26262 Part 2: roles, tailoring, supplier interface (DIA) and impact analysis.

04
Verification & validation testing

FMEDA, fault-injection, hardware metrics (SPFM/LFM/PMHF), HiL and vehicle-level safety validation.

05
Standards & engineering training

Role-based training tracks for managers, safety engineers and assessors — practical workshops with case studies from delivered projects.

06
Product certification

ISO 26262 ASIL A–D and IEC 61508 SIL 1–4 product certification through accredited group partners.

Cybersecurity · Business Groups

Five cybersecurity verticals

CS-01
Automotive Cybersecurity

ISO/SAE 21434 · UN R155 · UN R156

CS-02
Industrial Control / OT

IEC 62443 · NIST SP 800-82

CS-03
Medical Device Security

IEC 81001-5-1 · MDCG 2019-16 · EU 2017/745 / 746

CS-04
IoT & Consumer Products

UL 2900 · ETSI EN 303 645

CS-05
Information Systems & Privacy

ISO/IEC 27001 · 27701 · ISO 27799 · GDPR (EU 2016/679)

Cybersecurity · Services

TARA, CSMS, pen-testing and type approval

01
TARA & risk treatment

Item-level Threat Analysis & Risk Assessment per ISO/SAE 21434, with attack-tree and CAL determination for vehicle and component scope.

02
CSMS & SUMS audit

OEM and supplier-side Cyber Security Management System and Software Update Management System gap audits required for UN R155 / R156 type approval.

03
Secure development lifecycle

Embed cybersecurity activities through requirements, design, implementation, integration and post-development phases — including DIA with Tier-N suppliers.

04
Penetration & fuzz testing

Vehicle-bus, ECU, telematics, charging interface and backend penetration testing; CAN/LIN/Ethernet fuzzing; binary analysis and CVE triage.

05
Type-approval support (R155 / R156)

Technical Service routing through the group's TS qualification — dossier preparation, evidence packaging and witness-test execution.

06
ISMS & privacy certification

ISO/IEC 27001, 27701 and GDPR readiness for OEM IT, dealer networks and connected-vehicle backends.

Accreditations & Deliverables

Recognised qualifications, project-grade outputs

Group Qualifications
EU Notified Body NB 2406 (ENAVE, Italy)
Technical Service for UN R155 (Cybersecurity) & UN R156 (Software Update)
CNAS ISO/IEC 17020 — Inspection Body
CNAS ISO/IEC 17025 — Testing Laboratory · CMA accredited
CNAS ISO/IEC 17021 — Management-System Certification Body
ISO/IEC 17065 — Product Certification Body
Typical Deliverables
Item definition, HARA & TARA reports
Functional / Technical Safety Concept (FSC / TSC)
Cybersecurity Concept & Risk Treatment Plan
Safety / Cybersecurity Case & assessment report
CSMS / SUMS / SMS audit reports
Type-approval evidence package (R155 / R156)
Extension Standards · Sweden Scope

Harmonized standards under our certification scope

Functional Safety

Vehicles
ISO 26262
  • ISO 26262-2:2018
  • ISO 26262-3:2018
  • ISO 26262-4:2018
  • ISO 26262-5:2018
  • ISO 26262-6:2018
  • ISO 26262-7:2018
  • ISO 26262-8:2018
  • ISO 26262-9:2018
Road vehicle functional safety
ISO/IEC 17020 / 17065
Vehicles
ISO 21448
  • ISO 21448:2022
Safety of the Intended Functionality (SOTIF)
ISO/IEC 17020 / 17065
Machinery
IEC 61508
  • IEC 61508-1:2010
  • IEC 61508-2:2010
  • IEC 61508-3:2010
Type A standard for electrical safety-related systems
ISO/IEC 17065
Machinery
IEC 62061
  • IEC 62061:2021
Safety of machinery — Functional safety of safety-related control systems
ISO/IEC 17065
Machinery
ISO 13849
  • ISO 13849-1:2023
Safety of machinery — Safety-related parts of control systems — Part 1: General principles for design
ISO/IEC 17065
Machinery
Regulation (EU) 2023/1230
EU Machinery Regulation 2023/1230
ISO/IEC 17065

Cybersecurity

New Machinery Regulation (MR) — EU 2023/1230
prEN 50742:2025
Cybersecurity for machinery
ISO/IEC 17065
Industrial Control System Cybersecurity
IEC 62443
  • IEC 62443-2-4:2024
  • IEC 62443-3-3:2019
  • IEC 62443-4-1:2018
  • IEC 62443-4-2:2019
Industrial Automation and Control Systems (IACS) cybersecurity
ISO/IEC 17065
Key Takeaways

Why teams pick Wanve for safety & security

01

One contact, full standards coverage

From ISO 26262 to UN R155/R156, IEC 61508, IEC 62443 and ISO/IEC 27001 — a single interface for the whole compliance stack.

02

Notified Body backing

Direct access to NB 2406 and TS routing for UN regulations — avoid double-handling between consultancy and certifier.

03

EU + China engineering benches

Stockholm front-line engineers coordinate with the Chinese delivery team — bridging OEM HQ and European homologation timelines.

04

Project-proven methodology

Methodology hardened on Tier-1 powertrain FuSa programmes and OEM CSMS deployments — not slideware.

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