GAILUMED - Consulting specialized in Regulatory AffairsMay 202 minRegulatory AffairsWhat is ISO 13485?ISO 13485 is an international standard that specifies the requirements for a quality management system (QMS) applicable to medical devices.
GAILUMED - Consulting specialized in Regulatory AffairsMay 62 minRegulatory AffairsWhat is a Technical Manager for medical devices?A Medical Device Technical Manager is a professional appointed by a medical device manufacturer or distributor.
GAILUMED - Consulting specialized in Regulatory AffairsApr 232 minRegulatory AffairsHow is the current MDR for medical devices different from the previous MDD for medical devices?Here you will find a summary of the differences between the MDD and the current MDR
GAILUMED - Consulting specialized in Regulatory AffairsJan 3, 20236 minRegulatory AffairsHow to market medical devices and IVDs products in Spain and PortugalIn this Guide we teach you all the necessary steps established by the Health authorities in Spain and Portugal to market DM.