The Design History File (DHF) is a collection of documents that outlines the design history of a medical device. A DHF is one of the first documents that a regulatory body such as the FDA inspects for accrediting purposes. The primary function of the DHF is to provide...
Post-market surveillance or post-marketing surveillance (PMS) is a regulatory requirement for manufacturers of medical devices that need to collect and evaluate the experience obtained from the devices placed in a particular market. For example, as a manufacturer of a...
In the life sciences industry, document control denotes the processes and strategies used for managing the many different documents that move within the organization, amongst investors and sponsors, and regulatory agencies throughout the lifecycle of the product....
Medical Device Equipment Calibration is a procedure for detecting and fixing the uncertainties in measurements and bringing them to an acceptable level. The accuracy of the device has a great deal of importance, as it can seriously affect the diagnostic procedure and...
Remote audits offer an indispensable tool for improving and verifying medical device, pharmaceutical, and other life science organization’s compliance with the specific standards. Especially amongst the current travel restrictions due to the pandemic. Although,...
