Quality Management System and the In Vitro Diagnostic Medical Devices Regulation: a challenge to start-up companies
Quality Management System and the In Vitro Diagnostic Medical Devices Regulation: a challenge to start-up companies
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The in vitro diagnostics (IVD) industry is an innovative sector that improves the outcomes of health systems, the economy and most importantly patients’ quality of life. Europe is the second largest market in the world for IVD. Since 2017, the IVD industry is experiencing very demanding regulatory change (IVDR 2017/746) to ensure products more effective, safer and can be freely marketed in the European Union. The regulation affects all IVD aspects and, of course, the companies’ quality management systems (QMS). EpiDisease S. L. is a spin-off that develops IVDs based on epigenetics markers for the diagnosis of human diseases, and hence developing its QMS is essential. A fully implemented QMS based on ISO 13485:2016 is a money/time-consuming process; most of its requirements is about production process, however some of them that do pertain to product design-development steps. Therefore, a partial QMS implementation in the pre-production phase is an extremely beneficial way to ensure compliance with product development regulations, making the full QMS implementation less burdensome. EpiDisease is applying this strategy considering key changes of the 2016 version. This approach is allowing it to build and improve their QMS as they proceed through design and development, validation testing, conducting clinical trials, and finally market launch
Gisselle Perez Machado has received a PhD from the Universidad Autónoma de Barcelona- Barcelona – Spain. She is currently Quality Manager of EpiDisease S. L. Her research interests are in the areas of IVD design and development, quality, and management
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Diagnostics start-ups, ISO 13485:2016 QMS, Invitro diagnostic regulation, IVDR 2017/746
