Pro Bono Activities

The European Parliament has already enacted the Cyber Resilience Act (CRA), which must be implemented by 2026 by companies that market digital products in the European Economic Area. Therefore, the European Cyber Resilience Act (CRA) sets a new benchmark for cybersecurity for digital products and services, ensuring resilience and safety across the entire lifecycle. We provide tailored services to meet these rigorous requirements, offering end-to-end guidance that transforms compliance into a strategic and business advantage.

Your Advantage

1. Gap Analysis & Risk Assessment

Understanding and addressing compliance gaps is critical for achieving regulatory success. Our process begins with a detailed evaluation of your product’s current cybersecurity posture against CRA requirements. By identifying vulnerabilities and prioritizing areas for improvement, we provide a clear roadmap for achieving compliance and enhancing security.

2. Security by Design Integration

Embedding cybersecurity principles into your product’s design and development phase is essential for long-term security. Our early-stage consultation ensures that Security by Design is seamlessly integrated, while lifecycle management processes are implemented to maintain your product’s resilience throughout its operational life, minimizing risks post-launch.

3. Technical Documentation Preparation

Comprehensive and accurate documentation is a cornerstone of compliance. We assist in creating and maintaining essential records as mandated by the CRA, ensuring that your technical files are complete and validated. This preparation supports the certification process and builds confidence with regulatory bodies.

4. Testing and Validation

Rigorous testing is essential to meet CRA standards. We conduct security testing, including penetration tests, vulnerability assessments, and functional validations, to ensure that your product’s cybersecurity measures are robust. Conformance validation verifies alignment with legal requirements, ensuring readiness for certification.

5. Certification Support

Navigating the certification process can be complex. We provide expert guidance to help you achieve conformity assessment with notified bodies, ensuring a smooth journey to compliance. Our ongoing advisory services keep you ahead of evolving regulatory changes, maintaining your product’s alignment with the latest requirements.

6. Training and Workshops

Building internal expertise is a critical component of compliance. We offer customized training to educate your team on CRA requirements and best practices. For importers and distributors, our workshops clarify legal responsibilities under the CRA, helping them avoid compliance pitfalls and ensuring smooth operations across the supply chain.

Our Expertise

With decades of experience in cybersecurity and safety-critical systems, we have the expertise to tackle complex challenges your organization may face. Our services align with your business objectives and industry-specific technical needs. We conduct thorough risk assessments to identify vulnerabilities and provide guidance through implementation and certification. Our dedicated team supports you every step of the way, helping you meet regulatory standards and improve your security posture.

Leveraging advanced technologies is key to meeting regulatory demands and driving innovation. We provide AI-driven solutions that optimize every phase of medical systems development, from requirements engineering to lifecycle management. Our tailored approaches ensure compliance with industry standards while enhancing efficiency and product quality.

Your Advantage

1. AI-Driven Requirements Engineering

Automating the consistency and validation of requirements is essential for meeting stringent standards such as EU MDR, EN 62304, EN 62366-1, and ISO 14971. Using AI tools ensures that your requirements are accurate, complete, and traceable, reducing the risk of errors and accelerating the development process.

2. Architectural System Design

Optimizing system architectures for performance, safety, and cybersecurity is critical in medicine. We use advanced AI tools to model, evaluate, and refine system designs, ensuring they meet the highest standards for safety-critical applications. This approach enables developing robust and secure systems tailored to your unique needs.

3. End-to-End Traceability

Ensuring traceability across all phases of development is not just a compliance requirement but a best practice for reducing redundancy and ensuring quality. Our solutions provide seamless linkage from requirements to design, implementation, testing, and validation, enabling comprehensive oversight and control throughout the project lifecycle.

4. Digital Twins for Validation

Digital twins revolutionize the validation process by providing virtual prototypes that simulate and test system behaviors under various conditions. This innovative approach allows for early detection of potential issues, reducing development time and costs while ensuring optimal system performance.

5. Lifecycle Management

Managing the lifecycle of medical systems from design to decommissioning is a complex challenge that we simplify with AI-enabled workflows. Adhering to standards like EN 15288 and EN 62304, we establish comprehensive models and processes to streamline lifecycle management, ensuring compliance and efficiency at every stage.

6. Technical Documentation

Technical documentation is a cornerstone of regulatory compliance and product accreditation. We specialize in creating consistent, traceable, high-quality documentation supporting medical device certification, including Software as a Medical Device (SaMD). Our approach ensures that all documentation aligns with applicable standards and requirements, providing confidence and clarity for stakeholders.

Our Expertise

We are recognized experts in applying MBSE methodologies and AI to safety-critical environments. Our unique selling points include his comprehensive understanding of regulatory frameworks, our ability to align system design with compliance requirements, and our proven track record of developing innovative, reliable, compliant systems. These qualities make us a trusted partner for your technical consulting needs.

Ensuring agility and alignment between teams is critical for innovation and compliance with stringent regulatory requirements. Team Topologies, a proven framework for optimizing team dynamics, can help your organization improve collaboration, accelerate delivery, and ensure safety and quality in medical product development. We specialize in tailoring Team Topologies to meet the unique needs of the medical industry, enabling seamless integration of cross-functional expertise and compliance-driven workflows..

Your Advantages

1. Discovery and Assessment

The process begins with a comprehensive discovery and assessment phase. We work closely with your stakeholders to understand your organization’s current team structures, workflows, and challenges. By mapping existing interactions and dependencies, we uncover areas where alignment and efficiency can be improved, all while ensuring adherence to regulatory standards such as EU MDR and ISO 13485. The outcome is a diagnostic report that highlights key areas for enhancement.

2. Team Typology Design

Following the assessment, we move to the design phase, where we create a tailored Team Typology Blueprint. This involves categorizing your teams into core, enabling, platform, and stream-aligned types, ensuring that each team’s responsibilities align with business and regulatory requirements. We identify areas where decoupling can reduce cognitive load and develop a compliance-first interaction model that supports seamless operations.

3. Interaction Models and Communication Paths

The third step focuses on defining interaction models and communication paths. Effective collaboration between teams is essential, and we design service-oriented interaction contracts to enhance autonomy while maintaining clear communication channels. Escalation mechanisms and compliance touchpoints are addressed to ensure the new structure supports your organization’s regulatory obligations. Detailed interaction guidelines and communication protocols are delivered to guide this process.

4. Implementation and Training

In the implementation and training phase, we help transition your organization to the new team structure. This includes conducting workshops and training sessions to ensure that personnel are equipped to thrive in their roles. We implement tools to manage team interactions and workflows effectively, monitoring progress and addressing challenges as they arise. By the end of this phase, your teams will be fully operational within the new framework.

5. Continuous Optimization

Finally, we provide continuous optimization to ensure sustained performance and adaptability. We conduct regular reviews of team structures and workflows, with feedback from teams guiding ongoing improvements. This adaptive approach allows your organization to respond effectively to evolving business and regulatory demands. An optimization framework with key metrics is provided to track success over time.

Our Expertise

Our approach to implementing Team Topologies is highly customized and designed to address organizations' unique challenges. We provide tailored solutions that enhance team collaboration, streamline processes, and ensure regulatory compliance. With ongoing post-implementation support, we help your organization adapt to industry and organizational changes, ensuring long-term success.

 Achieving cost efficiency without compromising quality, safety, or compliance is essential in highly regulated industries. Design to Cost (DTC) is a strategic approach that integrates cost management into the product development lifecycle, ensuring that every decision aligns with financial and functional objectives. At STPSE, we help medical device manufacturers and healthcare organizations implement DTC strategies tailored to their unique needs, driving innovation while strictly adhering to regulatory requirements.

Your Advantages

1. Discovery and Baseline Analysis

The DTC process begins with a thorough discovery phase. We collaborate with your stakeholders to assess current product designs, cost structures, and market constraints. By analyzing existing data, identifying cost drivers, and mapping regulatory considerations such as EU MDR and ISO 13485, we establish a baseline for improvement. This phase concludes with a detailed report outlining opportunities for cost optimization and areas requiring focused attention.

2. Cost Target Setting and Design Goals

Once the baseline is established, we work with your team to define clear cost targets and align them with your product’s functional, safety, and regulatory requirements. These cost targets serve as benchmarks throughout the development process. During this phase, we identify key performance indicators (KPIs) and create a roadmap that integrates cost-efficiency goals into your design and engineering workflows.

3. Conceptual Redesign and Value Engineering

The third phase focuses on conceptual redesign and value engineering. Our experts conduct in-depth analyses to identify opportunities for material substitution, process improvements, and modular design approaches. By leveraging advanced modeling techniques, we ensure that cost-saving measures do not compromise product quality or compliance. This phase delivers detailed recommendations for redesigns and process optimizations that align with the cost targets.

4. Implementation and Supplier Integration

We support the transition to cost-optimized designs in the implementation phase by working closely with your engineering teams and suppliers. This includes integrating new components, materials, and processes into production workflows. We also establish collaborative partnerships with suppliers to negotiate better terms and ensure supply chain efficiency. Training sessions are provided to key personnel to ensure seamless adoption of the new design and cost strategies.

5. Monitoring and Continuous Improvement

The final phase ensures long-term success through monitoring and continuous improvement. We implement robust tracking systems to measure performance against the established cost and quality targets. Regular reviews and audits are conducted to identify additional savings opportunities and address emerging challenges. By fostering a culture of cost-conscious innovation, we help your organization stay competitive and compliant in a dynamic market.

Our Expertise

Our approach is highly customized, addressing the unique challenges medical device manufacturers and healthcare organizations face. We provide end-to-end support, from initial analysis to post-implementation monitoring, ensuring that your cost targets are met without compromising innovation or compliance. You can confidently achieve cost-efficient designs that drive value for your organization and customers.