Risk Management.
We combine risk analysis and regulatory compliance.

Risk Management.

Modern products are becoming more complex, regulatory requirements are increasing, and risks can be viewed in isolation with ever-greater difficulty. Software, connected systems, substance-related requirements, product safety, and market access are increasingly intertwined. We help companies assess risks in a structured manner, classify them according to regulatory requirements, and translate them into robust measures, processes, and decisions.

What we do.

We help companies systematically identify and assess risks in the context of products, markets, and regulatory requirements. In doing so, we consider not only individual risk areas but also the interactions between technical design, legal requirements, material specifications, cybersecurity, and international market access.

A key focus is on translating complex requirements into transparent risk assessments and auditable processes. We help classify risks, identify areas requiring action, and prioritize measures so that robust decisions can be made throughout the product lifecycle.

This creates a clear foundation for safe development, structured conformity assessment, transparent documentation, and a smooth market entry.

We make risks related to products, markets, and regulatory decisions manageable.

Services.

Today, risks arise simultaneously at many points of intersection. Technical requirements, software integration, cybersecurity, chemical compliance, and market requirements must therefore be considered together.

We provide support in the structured analysis of complex product risks and create transparency regarding relevant risk areas throughout the product lifecycle.

Added value

  • A holistic view of complex product risks
  • Fewer blind spots in risk assessment
  • Early transparency regarding critical issues
  • Better decision-making foundations for development and compliance
  • Greater safety for technically sophisticated products

Our services

  • Analysis of technical, regulatory, and organizational risk areas
  • Assessment of risks throughout the product life cycle
  • Examination of interfaces between hardware, software, and materials
  • Classification of material-related, functional, and electrical risks
  • Assessment of risks in the context of international market requirements
  • Documentation of relevant assumptions, assessments, and necessary actions

Not every risk carries the same regulatory or economic significance. It is crucial to assess risks in the context of specific requirements and to derive clear priorities from them.

We help classify risks from a regulatory perspective, assess their impacts, and prioritize measures based on relevance and urgency.

Added value

  • Clearer assessment of complex risk scenarios
  • Better prioritization of limited resources
  • Less uncertainty in regulatory decision-making
  • Transparent basis for approvals and action planning
  • Greater certainty when entering the market

Our services

  • Assessment of relevant risks in the context of legal requirements
  • Evaluation of regulatory impacts on products and markets
  • Classification of risks based on relevance, criticality, and need for action
  • Prioritization of measures based on technical and regulatory factors
  • Support in evaluating special cases and borderline situations
  • Preparation of results for business units and management

Risk assessments must not only be technically sound, but also documented in a transparent manner and permanently integrated into processes. This is the only way to ensure that decisions can be explained, reviewed, and refined later on.

We help you translate risk assessments into clear processes, responsibilities, and documentation structures.

Added value

  • Greater traceability and auditability
  • Clearer responsibilities throughout the product lifecycle
  • Less effort required for reviews, follow-ups, and approvals
  • More stable processes for recurring risk assessments
  • Greater certainty in regulatory decisions

Our services

  • Structuring risk assessment processes
  • Defining roles, responsibilities, and handoffs
  • Establishing traceable documentation structures
  • Supporting the integration of these processes into the product development process
  • Reviewing existing processes for traceability and consistency
  • Preparing evidence to meet internal and external requirements

Risk management is effective only when assessments lead to concrete decisions and actions. This requires clear priorities, understandable results, and structured oversight of implementation.

We translate risk assessments into reliable decision-making frameworks and help identify the next steps.

Added value

  • Faster and clearer decisions
  • Better management of regulatory and technical risks
  • Greater transparency regarding open issues and next steps
  • Less friction between departments
  • Greater certainty for development, compliance, and market entry

Our services

  • Deriving specific actions from risk assessments
  • Prioritizing actions based on risk and business relevance
  • Preparing overviews, status reports, and management information
  • Supporting coordination among departments
  • Assisting with the implementation and follow-up of defined actions
  • Structured preparation of decision-making documentation

Insights.

The new supply chain law:
A step toward precaution against human rights abuses.

The new supply chain law on compliance with human rights along the entire supply chain is to be passed by the end of 2021. With the new law, small to large companies will be confronted with new requirements. Now they are supposed to take extensive compliance measures (such as setting up a risk management system, conducting regular risk analyses, adopting a policy statement, etc.) to ensure the protection of human rights in connection with related supply chains.

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Get in touch.

How can we support you and your company? Please contact us!

Your direct line to MCG

Tobias Gabler

Tobias Gabler
Compliance & Risk

Phone: +49 89 383 46 89 0
Email:

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