Simulation-Driven Design with Integrated QA/RA

Simulation-Driven Design with Integrated QA/RA and Human Body Modeling (HBM)

We support the development of medical devices and biomechanical products through simulation-driven design, with Quality Assurance (QA) and Regulatory Affairs (RA) integrated from the outset.

By combining advanced FEA analysis with a QA/RA perspective, we ensure that both models and results comply with relevant standards and regulations, including ISO 13485, ISO 9001 and MDR. All simulations are based on validated test data and accurate CAD geometry to achieve high fidelity and reproducibility, while ensuring that documentation and traceability meet regulatory requirements.

The work includes material validation, skin pressure simulations, and advanced analyses using Human Body Models (HBM) to replicate realistic user conditions and biomechanical interactions. This enables evaluation of product performance in contact with the human body across a wide range of use cases.

Loading conditions are applied both as targeted forces and through full-system simulations—such as complete gait cycles—enabling both detailed component-level insights and system-level understanding.

In addition, we contribute to the development of quality management systems, technical documentation, and alignment with regulatory frameworks, ensuring that the entire development process remains consistent, compliant, and approval-ready throughout.

The result is reliable simulation data and robust design decisions, where quality, safety, and regulatory compliance are fully integrated into the development of both medical and biomechanical products.