Risk Management & Usability

A “good and safe product” from the customer’s point of view is not created at the end, but BEFORE development.

risikomanagement

Our offer

Qualifizierung von Mitarbeitern zur Durchführung von Risikomanagementaufgaben Aufbau einer Risikomanagementakte nach EN ISO 14971 Durchführung von Risikoanalysen (nach EN ISO 14971) gemeinsam mit Ihrem Team (Risiken finden und bewerten) Festlegung von geeigneten Maßnahmen zur Minimierung von Risiken Anforderungsmanagement (Requirements) zur Erstellung von belastbaren Lastenheften Erstellung eines konformen Risikomanagementberichts Ermittlung von User Needs Durchführung einer Task Analyse Aufbau der Gebrauchtauglichkeits-Akte Formative Studien Summative Studien

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Risk management & usability in medical technology

A “good product” from the customer’s point of view is not created at the end but BEFORE development. Consistent risk management and usability engineering provide the necessary development input (requirements) for your medical product. Our task is to support you in every phase of your projects. Thanks to our many years of experience, we know when to deliver which results.

The key is a consistent and well-founded requirements management for the product.

This is achieved through risk management and usability development, among other things. This demonstrably reduces the so-called “moving targets” during development and later application errors when entering the market.