ISO 14644 family of standard defines the requirements for cleanroom environment, thus where sterile devices need to be manufactured. Specifically, ISO 14644 is the international...
ISO 13485 audit is the methodology through which certification body performs the assessment of a quality system of an organization and issue the related...
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...
ISO 15189 is an international standard to be followed for the implementation and maintenance of quality management system of medical laboratory. ISO 15189 may...
An eCRF (electronic case report form) is basically a digital questionnaire used to collect data about a clinical study and research participants. The data...
According to the definition provided by European Medicine Agency (EMA), a companion diagnostic is an in-vitro diagnostic test that supports the safe and effective use of a specific medicinal...
Regulatory watch consists in the activity related to keep under active monitoring all the standards and regulation applicable to your medical devices and to...
In this article we will go through Article 110 of EU IVDR 2017/746.
We have already been discussing about the requirements associated to legacy devices, specifically in...
ISO 18113 defines the requirements associated to labelling for In-Vitro Diagnostic Medical Devices. We have extensively discusse about labelling in several occasions within QualityMedDev...
MDCG – Medical Device Coordination Group is a new entity that has been introduced with the EU Medical Device Regulation 2017/745 and In-vitro Diagnostic...
