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
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
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
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
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.