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Complass

Implement once, evidence many times

What you have done for ISO 27001 also counts for NIS2 and the CRA. Each framework is a module with guided steps and templates that you can add at any time.

Information security

Industry and products

IEC 62443 – industrial cybersecurity

OT security under IEC 62443 in one package: one booking includes the modules for all three roles.

Cyber Resilience Act (EU) 2024/2847

Product-related conformity: classification, Annex I, vulnerability handling, reporting obligations and CE marking.

To the framework

Machinery Regulation (EU) 2023/1230

From scope to CE marking, focusing on the cybersecurity requirements for control systems.

To the framework

Radio Equipment Directive – cybersecurity

Cybersecurity of connected radio products: scope and roles, requirements under Art. 3(3)(d), (e) and (f), harmonised standards (EN 18031), conformity assessment, documentation and the transition to the Cyber Resilience Act.

To the framework

Cybersecurity for medical devices (MDR/IVDR)

For manufacturers and suppliers in medical technology: secure development across the life cycle, minimum IT environment requirements, technical documentation, post-market surveillance and vulnerabilities.

To the framework

NIST SSDF and OWASP SAMM

For manufacturers of software and devices: secure development under the 42 tasks of the NIST SSDF, maturity under OWASP SAMM and a bridge to the CRA and IEC 62443-4-1.

To the framework

Product safety: GPSR – Regulation (EU) 2023/988

For manufacturers, importers, distributors, web shops and online marketplaces: risk analysis, documentation, mandatory information, accident reporting and recall.

To the framework

Critical infrastructure and sectors

German KRITIS Umbrella Act (KRITISDachG)

Physical resilience of critical facilities: applicability, registration, risk analysis, resilience plan and incident reporting. Applies in Germany only.

To the framework

DORA – Digital Operational Resilience Act (EU) 2022/2554

For financial entities and their ICT service providers: ICT risk management, incident reporting, resilience testing, register of information and contractual requirements under Art. 30.

To the framework

Energy Industry Act (EnWG) and IT security catalogue

IT security for networks, energy facilities and digital energy services under sections 5c to 5e EnWG: clarify your role, implement the applicable IT security catalogue, report incidents and provide evidence.

To the framework

IT security in hospitals: Section 391 SGB V and B3S

For hospitals of every size: obligations under Section 391 SGB V and implementation of the sector-specific security standard “Medical care” (B3S), linked with NIS2 and KRITIS.

To the framework

IT security guideline under Section 390 SGB V (KBV and KZBV)

For medical, psychotherapy and dental practices and medical care centres: all 92 requirements of the KBV and KZBV, graded by practice size, with evidence for the annual review.

To the framework

EU GMP Annex 11 – Computerised systems

For manufacturers of medicinal products and active substances: validate, operate and evidence computerised systems on a risk basis, ready for inspection.

To the framework

21 CFR Part 11 – Electronic records and electronic signatures

For companies with FDA-regulated records: scope, risk-based validation, operational controls, electronic signatures and inspection readiness.

To the framework

Data protection, data and AI

In preparation

In preparation: ISO 9001 – quality management Do you need one of them? Send an enquiry

What these frameworks cover
ISO 9001 – quality management
Build or transition a quality management system to the new 2026 edition: context, processes, risks and opportunities, control of documented information, internal audits and management review.

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Content is updated when laws or standards change. Legal texts are included in full in the portal, with the retrieval date.

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