Is My Software a CDx or Not?
https://www.devicesistemas.com/wp-content/uploads/2024/10/IVDSW.png Software as an In Vitro Diagnostic Medical Device First, before determining whether our software is a CDx or not, we must adequately justify that our software is an In Vitro Diagnostic Medical Device. (according to IVDR). An In Vitro Medical Device Software (IVDSW) is one that meets the definition of an In Vitro Diagnostic […]
E-commerce in the distribution and sale of healthcare products, tattoo and aesthetic instruments from Annex XVI, is it possible?
https://www.devicesistemas.com/wp-content/uploads/2023/07/e-commerce.jpg On March 21, the RD 192/2023 on healthcare products was published. This Royal Decree has brought a series of substantial changes especially for manufacturers and importers of healthcare products, products from Annex XVI, instruments for tattoos and semi-permanent and permanent makeup, and reprocessors of single-use products. This time we will focus on a modification […]