As a kit manufacturer, Chromsystems always stays abreast of the latest trends in clinical diagnostics. This includes the continuously growing regulatory requirements. A whole team of Chromsystems employees is dedicated to ensuring that CE-IVD-certified products meet all regulatory requirements now and in future. For example, we are working intensively on the new IVD-R, whose transitional period expires in 2022. To this end, Chromsystems has further expanded its regulatory capacity.
Various regulatory authorities, such as TÜV-SÜD, FDA and Anvisa, visit us in Gräfelfing at regular intervals to scrutinise the company and check quality management and compliance with applicable guidelines and standards such as DIN EN ISO 9001, DIN EN 13485 and ISO 13485 MDSAP. While this means more effort for us, it also ensures more security for our customers.