One-Stop Regulatory Compliance Support for Mechatronic Systems

Identify relevance. Structure next steps.

The starting point is a key question: Which regulatory requirements apply to your specific product – and in which role?

As part of a structured readiness check, we analyse:

• regulatory applicability (Machinery Regulation, CRA, AI Act),
• classification of software and digital components,
• roles along the value chain,
• existing risk management processes,
• documentation and compliance structures.

The goal is to establish a solid foundation:

Where are requirements not yet fulfilled? Where do requirements overlap? Which measures should be prioritised?

The readiness check creates transparency – before significant development effort begins.

Integrating safety in a systematic way

During the development and conformity phase, regulatory requirements are implemented technically and documented in a verifiable manner. We support you in:

Analysis and assessment

• integrated risk management
• supply chain assessment
• evaluation of training data and validation of AI systems

Technical implementation and assurance

• safeguarding of control and software functions
• implementation of measures for human oversight

Evidence and conformity

• creation and assessment of SBOMs
• preparation and support of conformity assessment procedures
• validation through systematic testing at component and system level

Compliance does not end with placing a product on the market

With the Cyber Resilience Act (CRA) and the AI Act, the regulatory focus is shifting significantly towards the operational phase. Manufacturers bear ongoing responsibility for security, update capability, transparency and compliance evidence. Compliance therefore becomes a continuous organisational task.

We support you in:

• establishing an integrated vulnerability, monitoring and incident management approach, including robust reporting processes
• implementing sustainable update and patch management processes to ensure long-term security in the field
• embedding regulatory requirements within governance and organisational structures, including the qualification of responsible personnel
• conducting systematic re-assessments in the event of changes and maintaining legally robust technical documentation
• managing and consulting of end-of-life and decommissioning processes, e.g., regarding data deletion and retention of documentation

The objective is to establish a resilient operational framework that proactively manages regulatory obligations, security responsibilities and liability risks.