FDA Requirements for UDI on Medical Devices
The UDI (Unique Device Identification) is a system used to uniquely identify medical device sold in a specific country, for example in United States. FDA started the implementation of UDI
How to write a Quality Manual fully compliant with ISO standards?
The quality manual is one of the most important documents for a company with a quality system in place, and in particular if the company is ISO 13485 certified. ISO
21 CFR Part 11: Requirements for Electronic Records and Signatures.
Introduction of 21 CFR Part 11 Requirements FDA 21 CFR Part 11 defines the requirements for the management of electronic records and electronic signatures. It is one among the best known
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.
