Our Services

---

Assessment and Gap Analysis:

Evaluating an organization's compliance with CRA and NIS-2 requirements, focusing on technical, procedural, and organizational gaps.

Security by Design: 

Embedding cybersecurity principles early in the system lifecycle using MBSE methodologies for traceable, model-driven security solutions

Third-Party Risk Management: 

Develop strategies to mitigate risks from suppliers and partners, meeting CRA and NIS-2 mandates through a Model-Based Cybersecurity Approach.

Organizational Mapping: 

Analyzing current team structures and recommending reorganization using Team Topologies principles to align teams with cost, agile, cybersecurity, compliance, and innovation goals through Team Topologies.

Collaboration Models:

Fostering a fast flow of information between development, operations, and security teams through dynamic interaction models.

Empowered Teams:

 Implementing self-sufficient teams responsible for specific system components, ensuring accountability, and speeding innovation cycles.

MBSE-Driven System Design: 

Using Model-Based systems engineering to design systems that integrate cybersecurity, organizational agility, and innovation seamlessly.

Scenario-Based Development: 

Simulating operational scenarios for cybersecurity threats and organizational bottlenecks, enabling iterative innovation.

Regulatory-Driven Innovation: 

Aligning MBSE models with EU MDR, CRA, and NIS-2 to ensure compliance while driving innovation in product design.

End-to-End Regulatory Guidance:

Providing comprehensive guidance through all phases of the regulatory approval process, ensuring conformity with the EU MDR, CRA, and NIS-2 requirements.

Documentation and Technical File Preparation: 

Supporting the creation and submission of robust technical documentation, risk assessments, and MBSE-driven models aligned with regulatory expectations.

Certification Pathways: 

Navigating the complexities of CE- Marking, Notified Body interactions, and certification audits.

Compliance Acceleration: 

Leveraging MBSE to expedite compliance processes, enabling faster, more efficient European product launches.

Ongoing Compliance Management:

 Establishing systems for continuous post-market surveillance and incident reporting, keeping products compliant throughout their lifecycle.

Grants and Funding Access: 

Identifying and securing grants to support research and development in cybersecurity and innovation.

Venture Partnerships:

 Connecting organizations with venture capital and private equity partners focused on cybersecurity and innovation technologies.

Risk-Adjusted ROI Models: 

Develop financial models to assess and justify investments in cybersecurity and innovation using MBSE for risk prediction through our partner.

Personalized Guidance: 

One-on-one or team mentoring to address your unique project challenges.

Best Practices: 

Expertise in leveraging SysML, MBSE tools, Team Topologies, and compliance with standards like ISO 13485, IEC 62304, and EU MDR.

Real-World Applications: 

Practical insights for implementing MBSE in the design and risk management of medical devices and Software as a Medical Device (SaMD).

Innovation-Driven Solutions: 

Strategies to streamline workflows, reduce costs, and accelerate time-to-market.