Process Validation for Medical Devices: Overview of FDA Requirements
What is Process Validation? Medical device process validation and the related IQ/OQ/PQ technique, is defined as the collection and evaluation of data, from the process design stage throughout production, which establishes
GAMP-5 Guidance for Computer System Validation
GAMP-5 guidance, the related "V model" and the different software categories used to simplify the validation activities are nowadays considered the internationally recognised best approach for computer system validation. GAMP
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: FDA Requirements
What is Verification and Validation Design Verification and validation are essential concepts for the design process of a medical device and it is of fundamental importance to fully understand
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.