ISO 20916 : Clinical Performance Studies for IVD devices
Clinical performance studies for In-Vitro Diagnostic devices are needed when analytical performance studies or other methods like literature research are not sufficient to evaluate the performance of the IVD device.
FDA Labelling Requirements: An Overview
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
What are the best Methods for Root-Cause Analysis ?
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
How to be compliant with ISO 27001?
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 and Usability Requirements for Medical Device
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
