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