Governance, Compliance & EU Regulation
With new European regulations such as the NIS2 Directive, the Critical Entities Resilience Directive, the EU Ai Act and the Cyber Resilience Act, the requirements for companies are increasing significantly. These requirements are also becoming relevant for many Swiss organizations – for example through business relationships with the EU, supply chain requirements, or regulatory obligations. Many companies are facing similar questions: Which regulations apply to us? Which measures are actually required? And how can different compliance requirements be implemented efficiently and in a practical manner?
SYNSPACE Switzerland supports companies in making complex EU regulations understandable, implementing them in a structured way, and documenting them in an audit-ready manner – with a risk-based approach that combines compliance and operational security.
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Typical challenges our clients face:
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Which EU regulations affect us at all?
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What does personal liability mean for management?
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How do we prepare for audits?
In Short: What are NIS2, CER, the EU AI Act and the Cyber Resilience Act (CRA)?
New EU regulations such as the NIS2 Directive, the Critical Entities Resilience Directive (CER), the Cyber Resilience Act (CRA), and the EU AI Act strengthen cybersecurity, resilience, and the responsible use of digital technologies across Europe. They affect operators of critical infrastructures, numerous industrial companies, as well as manufacturers of digital products and components. The objective of these regulations is to systematically manage cyber risks, protect supply chains, and increase the resilience of critical services. Many Swiss companies are also affected – for example through their role in European supply chains or through business activities in the EU market.
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Core elements of the regulation:
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NIS2: Cybersecurity risk management, incident reporting obligations, and stronger management accountability
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CER: Protection and resilience of critical infrastructures against physical and digital threats
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EU AI Act: Risk-based regulation of AI systems, including requirements for transparency, data quality, governance, and oversight – particularly for high-risk AI in safety-critical and industrial use cases
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CRA: Security requirements for products with digital components across the entire product lifecycle
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Together, these regulations create a Europe-wide framework for cybersecurity, resilience, and product security, requiring companies to implement structured risk management and sustainable security governance.
Industries with increased EU regulatory requirements
These industries are particularly affected by European cybersecurity and resilience regulations – whether due to their role as critical infrastructure, as operators of digital services, or as manufacturers of connected products:
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Energy & Utilities
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Industrial & Manufacturing
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Transport & Logistics
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Healthcare & MedTech
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Public Sector
Our Services
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Regulatory Gap Analysis
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Policy & Governance Framework
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Compliance Strategy & Roadmap
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Audit Preparation & Support
Our 4-Phase Approach

Scope & Applicability
Analysis of the company structure, services, and products to determine which regulatory requirements are relevant and to what extent they apply.

Gap Analysis & Risk Assessment
Assessment of the current maturity level compared to regulatory requirements, as well as identification of security risks, vulnerabilities, and compliance gaps.

Strategy & Roadmap Development
Development of a structured implementation strategy with prioritized measures, governance structures, and a realistic implementation roadmap.

Implementation Support & Audit Preparation
Support in the practical implementation of security and compliance measures as well as preparation for audits, evidence, and regulatory assessments.
Key Deliverables
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Regulatory Applicability Assessment
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Gap and Risk Analysis
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Compliance Strategy & Implementation Roadmap
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Policy and Process Framework
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Audit Preparation & Evidence Documentation
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Enablement of your teams through training & workshops
Enablement of your teams through Trainings & Workshops
- In-House – delivered on-site at your organization
- Virtual – online, interactive sessions
- Public Courses – open enrollment trainings
- Train-the-Trainer – enable internal multipliers
- Hands-on – real use cases from our consulting practice
- Interactive – workshops instead of traditional lectures
- Up-to-date – latest regulations and standards
- Swiss context – relevant, practical examples
- Enablement-focused – your teams become internal experts
- Role-based – tailored for executive and operational levels
Duration: 1 day (Executive: 3h) | Level: Executive & Operational | Target Audience: C-Level, Compliance Officers, Risk Managers
Content:
- NIS2 Directive – Requirements & Scope
- CER Directive – Resilience of critical entities, management liability & fines, implementation roadmap
Benefits: Regulatory clarity for decision-makers
Duration: 1 day (Executive: 3h) | Level: Executive & Operational | Target Audience: Specialists and managers from product development, quality management, regulatory affairs, IT security, manufacturers of digital products distributed in the EU
Content:
- CRA Scope – which products are affected? Essential Requirements
- Product Lifecycle Security
- CE Marking & Conformity Assessment
Benefits: Regulatory clarity for decision-makers
Duration: 2 days | Level: Executive & Operational | Target Audience: Product Managers, Developers, Security Engineers, Compliance Officers, Quality Managers, Management
Content:
- Overview of cybersecurity and product safety in the context of connected agricultural machinery
- Contextualization of ISO 24882 within the regulatory framework (including the Cyber Resilience Act, Machinery Regulation, ISO/SAE 21434)
- Fundamentals and objectives of ISO 24882, as well as its requirements for organizations and products
- Introduction to risk analysis and risk assessment (including damage scenarios and threat assessment)
- Derivation and implementation of technical cybersecurity requirements for products
- Consideration of the entire product lifecycle, including vulnerability management and supplier handling
- Documentation and evidence management in accordance with ISO 24882
Roles, responsibilities, and organizational integration within the company - Practical examples and application of the risk assessment process
- Mapping of ISO 24882 to regulatory requirements such as the Cyber Resilience Act and the Machinery Ordinance
Benefits: Participants gain a thorough understanding of cybersecurity requirements for connected agricultural machinery and agricultural products. They learn how regulatory requirements and standards are translated into concrete measures and how risk analyses serve as the basis for secure and compliant.
Duration: 1 day (public) or 2 days (in-house, including customer case study) | Level: Operational / Advanced | Target Audience: Security engineers, developers, system engineers, architects, quality managers, compliance officers
Content:
- Introduction to risk-based approaches to cybersecurity and their importance for secure systems and products
- Overview of regulatory requirements such as the Cyber Resilience Act and relevant standards such as ISO/SAE 21434 and ISO 24882
- Fundamentals of the Threat Analysis and Risk Assessment (TARA) methodology
- Structured execution of a risk assessment:
– Definition of the intended purpose and system boundaries
– Identification and evaluation of assets and cybersecurity properties
– Development of damage scenarios and impact assessment
– Threat modeling (including methods such as STRIDE)
– Assessment of threat occurrence and derivation of cybersecurity risks
Derivation of measures:
– Risk treatment strategies
– Definition of cybersecurity goals, controls, and requirements - Adaptation and combination of various methods and standards depending on the project context
- Implementation of cybersecurity requirements and demonstration of security (compliance & auditability)
Benefits: Participants learn to conduct risk analyses in a structured and practical manner and to translate regulatory and normative requirements into concrete security measures. They develop a clear understanding of how to derive robust cybersecurity measures from assets, threats, and risks
Duration: 2 days | Level: Operational / Advanced | Target Audience: Security Engineers, Software & System Developers, System Engineers, Architects, Product Security Engineers, Quality and Compliance Managers
Content:
- Introduction to cryptography in the context of product security and regulation (CRA, EU AI Act)
- Fundamentals of key cryptographic mechanisms (symmetric/asymmetric encryption, hashes, MACs, digital signatures, PKI)
- Typical attacks and vulnerabilities in cryptographic systems and their assessment
- Selection and application of appropriate cryptographic methods depending on the use case, including secure system integration
- Mapping to regulatory and normative requirements (CRA, EU AI Act, ISO/SAE 21434)
Benefits: Participants learn to apply cryptographic methods in a secure and purpose-driven way, identify vulnerabilities, and translate security requirements in the context of CRA and the EU AI Act into robust and implementable system solutions.
Workshops:
- 0.5–1 day – Current state vs. NIS2/CER/CRA
- 1 day – Leveraging synergies between regulations
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Trainings
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Workshops
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Consulting
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Assessment (Support)
