Device Master Record
The device master record is a design document specifically requested by the FDA Quality System Regulation, as per 21 CFR 820.181. If we follow the definition reported in the regulation:
Design Verification vs Design Validation: What are The Differences?
Introduction to Verification vs Validation Design verification and validation are critical components of the design process when developing a medical device. It is vital to have a clear understanding of
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
