BSI Group Europe
Full Quality Assurance (Module H) & Secure Development Lifecycle Auditing
The optimal certification route for large enterprise manufacturers releasing dozens of connected products per year who want to avoid per-product Notified Body delays via Module H full quality assurance.
Leading European certification body specializing in full quality management system audits under Module H.
Statutory Capability & Article Coverage Matrix
How BSI Group Europe performs against non-negotiable statutory mandates of Regulation (EU) 2024/2847.
| CRA Legal Obligation | Statutory Reference | Tool Capability Status |
|---|---|---|
| Technical Documentation Dossier | Annex VII | Ingest & Link Rails |
| EU Declaration of Conformity | Annex V | Native Auto-Dossier |
| Coordinated Vulnerability Disclosure (CVD) | Article 10 & RFC 9116 | Workflow Only |
| 24-Hour ENISA Early Warning Dispatch | Article 14 (Active Sept 2026) | No |
| Substantial Modification Diff Engine | Article 22 | Manual Check |
| Binary Firmware Disassembly & SCA | Annex I Part I (1)(a) | Hardware Lab Only |
| Air-Gapped / Island-Mode Deployment | Data Sovereignty & IP Protection | Bespoke Consulting |
Architectural Fit & Deployment Analysis
Audits the organization's entire secure development pipeline—from threat modeling in design, through cryptographic key management in production, to automated security patching post-market.
The Module H strategic advantage: Once BSI certifies your secure development lifecycle, you do not have to submit every single product variant for individual laboratory examination.
Process-heavy: BSI audits policies, traceability matrices, and testing records. They rely on the manufacturer's own tool telemetry rather than conducting low-level reverse engineering.
Pricing, Packaging & Total Cost of Ownership (TCO)
- Annual surveillance audits
- Mandatory auditor travel expenses
A certified quality management system does not exempt products from Annex I essential requirements. MSAs can still sample and impound non-compliant products on the market.
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