Ancillary medicinal substances are medicinal products that are incorporated within a medical device, with the device being the primary driver of its mode of action. While we have previously discussed

ISO 13485 audit is the methodology through which certification body performs the assessment of a quality system of an organization and issue the related ISO 13485 certificate, upon successful completion

As we have already mentioned in other articles, the in-vitro diagnostic sector is undergoing to significant changes due to introduction of the EU In-Vitro Diagnostic Regulation; one of these changes

ISO 15189 is an international standard to be followed for the implementation and maintenance of quality management system of medical laboratory. ISO 15189 may be consider the analogue of ISO