QualityMedDev

Although there are different ISO standards which define the requirements for labelling related to medical device, such us ISO 15223-1 and ISO 20417, FDA has

Performing an investigation in case any type of deviation occurs is of fundamental importance nowadays and root-cause analysis methodologies play a fundamental role within the

Tips for implementation of the ISMS ISO 27001 is an international standard providing requirement for the implementation of the information security management system (ISMS). Many medical

Human factors engineering plays a fundamental role in the design process for medical device. It is an essential part of the design history file. The

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

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

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

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

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

New Requirements for Post-market Surveillance The EU MDR 2017/745 and IVDR 2017/746 provides a big revolution for post-market surveillance, with a new framework of requirements which