[The Current Status and Suggestions of Registration Quality System Audit for Entrusted Production According to Shanghai Medical Device Regulation of Marketing Authorization Holder].

This study expounds on the current status of the registration quality system audit for entrusted production in the past three years in accordance with Shanghai's medical device regulations for marketing authorization holders (MAH). Through sorting and analyzing typical non-conformities, highlighting the main responsibilities of registrants, and clarifying the obligations and rights of relevant parties. Meanwhile, it also provides a certain useful reference for medical device marketing authorization holders and relevant regulators.

[Risk Analysis of Intravascular Shockwave Catheter and Discussion of Critical Control Points throughout Life Cycle].

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.