Manufacturers of medical devices need to obtain CE marking on their products, before placing it on the European market. There are a number of regulatory requirements for medical devices which can be found in the Medical Device Directive or Regulation (MDD \/ MDR). The technical documentation of the product should be well structured and complete to demonstrate compliance to these regulatory requirements.<\/p>\n\n\n\n
Garza MD can be of service in setting up, writing and \/ or structuring of the necessary Technical Dossiers and Design History Files. This assistance can take place in several stages of the product life cycle. From conception to market introduction and post-market activities.<\/p>\n\n\n\n
Gap analysis for compliance<\/p>\n\n\n\n
Classification of devices, systems and accessories<\/p>\n","protected":false},"excerpt":{"rendered":"
Manufacturers of medical devices need to obtain CE marking on their products, before placing it on the European market. There are a number of regulatory requirements for medical devices which can be found in the Medical Device Directive or Regulation (MDD \/ MDR). The technical documentation of the product should be well structured and complete […]<\/p>\n","protected":false},"author":1,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"footnotes":""},"class_list":["post-48","page","type-page","status-publish","hentry"],"yoast_head":"\n