eCRF and Clinical Trials
An electronic case report form (eCRF) serves as a fundamental tool in the collection of data for clinical studies and…
Companion Diagnostic: Overview of the Regulation
According to the definition provided by European Medicine Agency (EMA), a companion diagnostic is an in-vitro diagnostic test that supports…
Regulatory Watch
Regulatory watch consists in the activity related to keep under active monitoring all the standards and regulation applicable to your…
Analytical Performance of IVD Devices
Analytical performance for in-vitro diagnostic device is one of the main factor that need to be taken in consideration before…
Article 110 of EU IVDR 2017/746 : An Overview
In this article we will go through Article 110 of EU IVDR 2017/746. We have already been discussing about the…
Performance Evaluation Plan according to IVDR 2017/746
Performance Evaluation Plan is one of the key requirements according to IVDR 2017/746 and it is useful to define the…
ISO 13485 Mandatory Documents
In this short article we will go through the requirements related to mandatory documents for ISO 13485, especially in relation…
Summative Evaluation according to IEC 62366
Summative evaluation is one of the methodology specified by the IEC 62366 for the evaluation of the usability of medical…
ISO 18113 : Labelling Requirements for IVD Medical Devices
ISO 18113 defines the requirements associated to labelling for In-Vitro Diagnostic Medical Devices. We have extensively discusse about labelling in…
ISO 23640: Stability Evaluation for IVD Medical Devices
For in-vitro diagnostic devices, ISO 23640 plays a key role as it defines the requirements related to the stability of…