Abstract
This study summarizes the clinical application, technical characteristics, and production process of intravascular shockwave catheters. It collects statistics on adverse events of related products from the MAUDE database, analyzes the causes of adverse events and failure modes of intravascular shockwave catheters, and identifies risk points. Based on the whole life cycle management method of medical devices, combined with product risks and the requirements of Good Manufacturing Practice for Medical Devices and related appendices, the critical control points of such products in the design and development, manufacturing, sales, and use stages are discussed.
Published Version
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a call