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Four sets of rules, two worlds, one partner.

An assessment for the AI Act, the Machinery Regulation, the Cyber Resilience Act, and NIS2. Plus consulting services for IT and OT security, ranging from awareness training to critical infrastructure. And an ecosystem that handles implementation. Here you’ll find detailed information on all our services.

Four sets of regulations are combined into a single certification document

How We Work with You

A lifecycle from clarity to ongoing security. A one-time assessment and roadmap, with ongoing security and verification. A single project leads to lasting, verifiable compliance.

Step 1 · One-time

Convergence Assessment

What regulatory frameworks do you comply with, and where do you stand today? Record it once, use it across all regulatory frameworks.

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Step 2 · One-time

Roadmap & Implementation

Prioritized measures featuring quick wins and a consolidated set of controls, implemented in collaboration with our partners.

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Step 3 · Program for Your Supplier Base

Supplier Enablement

CRA documentation for your supplier base. A program provided to your suppliers to serve as the basis for your declaration of conformity.

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Step 4 · Ongoing, recurring annually

Audit Readiness as a Service

Continuously monitors your audit and compliance capabilities, with annual reassessments, a complete audit trail, and version control.

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Additional Services

IT & OT · On-site or Remote

Security Awareness Training

Practical training for production and office staff, tailored to your OT environment. Includes handouts, exercises, and sample solutions that work in everyday situations.

  • OT Security Awareness for Production Teams
  • IT Security Awareness for All Employees
  • Directly addresses the training requirements of 8 of the 11 frameworks
KRITIS · Municipalities & Energy Providers

Critical Infrastructure Consulting

Assessment of compliance with the minimum ICT standards, which are already mandatory for the electricity sector. Compact, affordable, and with a clear report on the results.

  • ICT Assessment for Energy Utilities
  • A Quick IT Check for Municipalities
  • Prioritized Actions and Results Report for Management
Workshops · German & English

Compliance Workshops on Entering the EU Market

A structured workshop series for manufacturers looking to enter the EU market. Topics range from manufacturer status to the Machinery Directive and the Cyber Resilience Act.

  • Clarification of Manufacturer Status and Roles
  • Requirements for each set of regulations with strict deadlines
  • The result is a 12-month roadmap that can be planned

The New Reality of Compliance

Four sets of EU regulations are affecting the mechanical and plant engineering sectors almost simultaneously. As a manufacturer and operator, you are subject to both sets of obligations. Obligations, deadlines, and liability all converge.

since August 1, 2025
RED EN 18031

Cybersecurity requirements for wireless devices with Bluetooth or Wi-Fi are already in effect. They will be replaced by the CRA as of December 11, 2027.

today
NIS2 Takes Effect

Cybersecurity Obligations for Operators. Reporting Requirements and Liability of Management.

2.8.2026
AI Act Transparency

Transparency requirements under Article 50 apply. Existing systems must be labeled by December 2, 2026.

11.9.2026
CRA Reporting Requirements

Actively exploited vulnerabilities and serious incidents must be reported (Art. 14).

20.1.2027
Machinery Regulation

For the first time, digital and AI risks are being considered as part of product safety.

2.12.2027
AI Act: High Risk

Obligations for autonomous high-risk AI (Annex III), as newly established under the Digital Omnibus.

11.12.2027
CRA Key Responsibilities

Security by Design for products with digital elements.

2.8.2028
AI Act: AI in Products

Requirements for high-risk AI in regulated products (Annex I). Machine learning is largely covered by the GDPR.

70 %
Cybersecurity requirements overlap. Those who address them separately end up paying multiple times.
12 to 18
Conformity assessment and technical documentation require several months of lead time. Anyone who needs to deliver in 2027 should get started now.
In 30 minutes, we'll help you figure out which of these deadlines you really need to meet and which ones you can ignore.Schedule a Quick CheckCall now

A dual role, two sets of responsibilities

Machinery and plant manufacturers are almost always both at the same time. This is precisely where the leverage of convergence is greatest.

Role 1 · Manufacturer

Connected products with digital and AI features

  • RED EN 18031 for radio equipment, already in effect
  • Cyber Resilience Act (EU) 2024/2847
  • Machinery Regulation (EU) 2023/1230
  • EU AI Act, Article 15 on High-Risk AI

Security by Design, technical documentation, and product conformity assessment.

Role 2 · Operator

In-house OT and production infrastructure

  • NIS2 Directive (EU) 2022/2555
  • EU AI Act with operator obligations under Articles 4 and 26
  • Minimum ICT Standard (BACS / Switzerland)
  • ISO/IEC 27001 as the Foundation of an ISMS

Risk management, reporting requirements, and ongoing, safe operations.

An assessment covers both roles.

Those who manage the two separately create two separate compliance frameworks. We integrate both into a common ISMS framework based on ISO 27001, with IEC 62443 serving as a bridge between product security and operational security. Manufacturer and operator responsibilities are consolidated into a single system.

Three Pillars, a Foundation of Security

Each pillar follows the same logic of legal requirements, certifiable evidence, and proven methodology. Which of these components you actually need depends on your products, markets, and roles.

PILLAR 1 · AI Governance & Security

Is your AI legally compliant?

  • EU AI Act, Article 15 on Robustness and Cybersecurity
  • ISO/IEC 42001 as a Certifiable AI Management System
  • NIST AI RMF with Govern · Map · Measure · Manage
PILLAR 2 · Product Law

Is your product allowed to be imported into the EU?

  • Machinery Regulation (EU) 2023/1230, effective January 20, 2027
  • Cyber Resilience Act with "Security by Design" Effective December 11, 2027
  • IEC 62443 as a Technical Bridge to OT Security
PILLAR 3 · Cyber Resilience

Can your business weather a crisis?

  • NIS2: Reporting Requirements and Management Liability
  • ISO/IEC 27001 as a Common ISMS Foundation
  • Minimum ICT Standard (BACS/CH) for Clinical Practice
We'll see in 30 minutes whether all three pillars are working for you.Schedule a Quick Check

The Convergence Matrix

Four sets of regulations, eleven frameworks, hundreds of individual requirements. Our convergence matrix condenses all of this into 14 measures and shows which ones count toward multiple requirements. This saves you three to four times the project effort.

11/11
Risk management is a key component of all eleven frameworks. Once properly established, it counts toward all eleven.
10/11
Logging and audit trails support ten frameworks with a single configuration.
9/11
Technical documentation fulfills nine disclosure requirements at once.

A single unaddressed vulnerability often affects seven sets of regulations at once. The matrix reveals where your greatest opportunities and your most dangerous vulnerabilities lie only when we apply it to your company. You can only learn this through a conversation—not online.

Schedule a Quick Check

The Rules in Detail

Four key trends will shape the coming years in mechanical and plant engineering. We understand them in detail and translate them into a feasible roadmap.

Already in effect · Manufacturers and operators

EU AI Act

The AI competence requirement under Article 4 has been in effect since February 2025, while the labeling requirements under Article 50 have been in effect since August 2026, with a deadline of December 2, 2026, for existing systems. High-risk requirements will be phased in through 2028. Of the ten planned standards, only one has been published, and none have been cited as legally binding. Ironically, the one on safety is missing.

  • AI Inventory and Risk Screening as a Starting Point
  • AI Security Status Report
  • Training on Mandatory AI Competency
Reporting Requirements Effective September 11, 2026 · Main Requirements Effective December 11, 2027

Cyber Resilience Act (EU) 2024/2847

Security by Design for products with digital components, vulnerability management throughout the entire lifecycle, and mandatory SBOM reporting. The reporting requirement applies retroactively to products that have already been shipped. Without a declaration of conformity, sales may be suspended starting at the end of 2027.

  • Product Scope and Requirements from Annex I
  • Supplier Verification Through Our Enablement Program
  • An assessment also applies to Art. 15 of the AI Act
Effective January 20, 2027 · Product Law

Machinery Regulation (EU) 2023/1230

Replaces the Machinery Directive with an abrupt transition and no grace period for selling off existing stock. For the first time, digital and AI risks are included in product safety requirements, including protection against tampering with safety-critical software and documentation requirements regarding modifications and software versions.

  • Gap Analysis of Your Technical Documentation
  • Compliance Roadmap Leading Up to the Deadline
  • Alignment with the CRA and the AI Act in a Single Step
BACS · Switzerland

Minimum ICT Standard

The Swiss benchmark for ICT resilience, based on the NIST Cybersecurity Framework and comprising over 100 specific measures. Already mandatory for the electricity sector; for other sectors, it serves as the gateway to regulated supply chains.

  • Progress Assessment for Each Measure
  • Prioritized Implementation for Operations and Emergencies
  • Compliant with ISO 27001 and NIS2

White Papers & Publications

White Paper Cover
White Paper

Regulatory Cybersecurity in Mechanical and Plant Engineering

From ISG and the Minimum ICT Standard to PrSG/MaschV, the EU Machinery Directive, NIS2, and the Cyber Resilience Act. This white paper provides a Swiss perspective on which national and EU regulations apply, what deadlines are in effect, and how you can efficiently meet all requirements using an integrated approach.

Request a White Paper
Stefan Hungerbühler, CEO of SecureComply GmbH
Stefan Hungerbühler
CEO of SecureComply GmbH
LinkedIn
Expertise on an equal footing

Do you have any questions?

In this 30-minute quick check, we'll show you which regulations you need to comply with and where your greatest leverage lies.

© SecureComply GmbH