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 placing an IVD device on the market. According to IVDR
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 requirements associated to legacy devices, specifically in the context of medical device and
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 clinical evidence needed to support the safe use of an
ISO 13485 Mandatory Documents
In this short article we will go through the requirements related to mandatory documents for ISO 13485, especially in relation to procedure, and we provide evidence of how QualityMedDev can
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 devices. Usability is one of the key factors to take
