Susanne Golombek

Clinical validation: A definition

By Susanne Golombek December 9, 2024 Leave a comment

The term “clinical validation” is also frequently used in the context of medical devices. For example, the German Federal Ministry of Education and Research (BMBF) has published a guideline on the clinical validation of innovative medical technology solutions (only available in German). The FDA also refers to clinical validation. What is clinical validation? What distinguishes…

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Clinical investigations of medical devices under the MDR – The regulatory pathway

By Susanne Golombek November 8, 2024 Leave a comment

The requirements for clinical investigations to evaluate a device have increased enormously under the MDR. Learn the most important things you need to know about the regulatory pathway for clinical investigations under the MDR here. 1. Clinical investigations of medical devices a) Definition and objectives According to the MDR, a clinical investigation is During clinical…

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