Case Study

Efficient Onboarding as a Success Factor for PMCF Studies

Efficient Onboarding as a Success Factor for PMCF Studies

Pages 5 Pages

Starting Point Auto Tissue Berlin GmbH was founded more than 20 years ago as a spin-off from the Cardiac Surgery Clinic of the Charité Berlin and produces cell-free biological implants. Currently, the only commercially available product is a cell-free patch derived from the equine pericardium. This patch is used to repair defects in the cardiac and vascular systems, primarily in children. The risk class III product has a CE certificate and is also approved in Russia, Saudi Arabia, Iran as well as India. Figure 1: Manufacturing processes and products of Auto Tissue Berlin 1As part of the recertification process due at the end of 2022, a PMCF study was planned to generate further data on the clinical safety of the product.

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