Medical Devices containing Ancillary Medicinal Substances
Ancillary medicinal substances are medicinal products that are incorporated within a medical device, with the device being the primary driver…
ISO 13485 Audit
ISO 13485 audit is the methodology through which certification body performs the assessment of a quality system of an organization…
EU Reference Laboratories according to IVDR
As we have already mentioned in other articles, the in-vitro diagnostic sector is undergoing to significant changes due to introduction…
ISO 15189: QMS for Medical Laboratories
ISO 15189 is an international standard to be followed for the implementation and maintenance of quality management system of medical…
