If you are a medical device company, you will understand the need to comply with both international and regional regulatory rules and regulations. A very important regulatory quality standard that is enforced by the US FDA (21 CFR Part 820.198) in the North American...
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...
