Requirements- & Usability Engineering

We bring your product ideas to market:
structured, efficient, and compliant.

Lena Jünemann

Compliance Specialist / Consultant

Innovation as the Key to Commercial Success

In highly regulated industries such as medical technology, biotechnology, and pharmaceuticals, innovation is the key to market success. To gain an advantage under strict standards and increasing competitive pressure, companies need more than compliance alone. Demonstrable clinical and economic value, clear structures, and a forward-looking development strategy are essential.

We support you in developing a sustainable vision for the future, translating it into precise customer and stakeholder requirements, and transferring these into a robust system architecture. Our approach fosters agile, standards-compliant development processes and minimizes unnecessary revisions, creating space for true innovation.

Clear specification of requirements and success criteria
Agile development with defined future options
Process optimization with maximum compliance

Efficient and Reliable Support for Your Development Process

Defining product requirements, clarifying intended use, navigating standards, and addressing risks early, all of this saves time and prevents common mistakes. Well-structured processes not only ensure compliance but also significantly improve development workflows. We support you with proven methods and in-depth expertise.

Strategy Development

We combine innovation with standards-compliant implementation, always considering not only current but also future market requirements. We help you structure development, approval, and market launch in a way that is both systematic and agile, all the way through to product optimization.

Intended Use and Requirements

Through systematic analysis, both current and future customer requirements are identified, preventing unexpected changes later on. Defining the intended use, stakeholder requirements, and key performance characteristics plays a central role in this process.

Technical and Regulatory Requirements

Instructions for use of medical devices must be clear, complete, and standards-compliant, in line with the requirements of MDR, IVDR, and standards such as IEC 82079-1, AAMI TIR49, and relevant ISO norms. Proper labeling and structured documentation are essential to ensure safe use and minimize risks.

Validation and Development Testing

We support the development and evaluation of mock-ups, test scenarios, as well as the validation and verification of products. We also review existing systems with a focus on usability, efficiency, and regulatory compliance, and assist in their structured optimization.

Risk Management and Usability Engineering

For the safe development of medical devices, risk analysis is essential. Standards such as ISO 14971:2019 define the requirements for the risk file. With structured processes, we reduce your effort and help avoid errors right from the start. Good usability creates real customer value and gives your product a competitive edge.

Together with your experts, we optimize usability and workflow, from definition through to validated usability. We provide comprehensive support in risk management and usability to ensure your medical devices are safe, efficient, and ready for the market.

Risk Management in accordance with ISO 14971

Structured risk analyses in accordance with ISO 14971
Risk-based classification and prioritization of actions
Integration of data protection (GDPR) and cybersecurity (DIN EN 80001-1)
Support with software safety classification
Lean CSV for digital systems, including validation master plans and checklists

This way, you avoid common pitfalls, minimize rework, and gain early planning certainty for approval and market launch.

Usability Engineering

Derivation of user requirements and main operating functions
Creation of standards-compliant Usability Engineering Files (IEC 62366, MDR, FDA)
Conducting formative & summative evaluations in clinical simulations
Collaboration with training centers and expert networks
Optimization of user experience from a regulatory perspective

The results feed directly into the technical documentation, enhancing both product safety and market opportunities.

✓ Integrated Risk & Usability Management
For safe and market-ready medical devices.

✓ Reduced Documentation Effort
Efficiency through risk-based approaches.

✓ Realistic Test Environments
Validation in OR and ICU simulations.

✓ Verified Compliance
Secure approval & market release.