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 also some specific requirements that

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 regulated environment. Events and Casual

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 devices are nowadays based on

ISO 62366 plays a fundamental role in the design process for medical device as it explains the requirements related to usability. Usability studies are an essential part of the design

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