QualityMedDev

General Requirements It is important to demonstrate that top management reviews the suitability, adequacy and effectiveness of the organization’s quality system at defined intervals and with sufficient frequency. This is to

GXP requirements became more and more important in the last years. In this post, we provide an easy guideline to GXP compliance. In the last years, the complexity of the

IEC 62304:2006 is an internationally recognised medical device standard which provides a framework for the development, testing and maintenance of software used as or within medical devices. It

There is no doubt that CAPA (Corrective and Preventive Actions) is one of the most important process of any Quality Management System based on ISO 13485:2016. We have already been

Who are Economic Operators according to EU MDR? The term Economic Operators is explained in article 2 of EU MDR and IVDR and it refers to manufacturers, authorised representative, distributors