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

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 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

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 website. For example in relation to

For in-vitro diagnostic devices, ISO 23640 plays a key role as it defines the requirements related to the stability of in-vitro diagnostic reagents used within an IVD devices. We have