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…
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…
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…
