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- W4386197814 abstract "Medical and in vitro diagnostic devices shall be designed and manufactured in such a way that, during normal conditions of use, they are suitable for their intended purpose and they shall not compromise the clinical condition or the safety of patients, the safety and health of users, or where applicable, other persons (MDR 2017/745). In order to achieve this, manufacturers of medical and in vitro diagnostic medical devices must have, in accordance with the applicable EU regulations, a quality management system (QMS) in place to ensure compliance at all times with the claimed safety and performance requirements of these regulations, even when mass-produced. The continued effectiveness of the quality management system must be ensured through appropriate processes and controls, including regular internal audits. In addition, notified bodies and national authorities are also required to verify that manufacturers, critical suppliers, and professional users have implemented a quality management system that meets legal requirements. This chapter describes and explains which legal and normative regulations determine the scope and content of audits and inspections, which types of audits and inspections occur, and how an internal audit is to be planned, conducted, documented, and tracked. Furthermore, we describe when and to what extent audits are carried out by a notified body, how inspections of manufacturers and users are performed, which priorities are set during inspections, and how to prepare for an audit or inspection. Finally, we discuss the specifics of inspections by the US Food and Drug Administration and go into detail what Medical Device Single Auditing Program is and its consequences for medical device manufacturers." @default.
- W4386197814 created "2023-08-27" @default.
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- W4386197814 date "2023-01-01" @default.
- W4386197814 modified "2023-09-25" @default.
- W4386197814 title "Mastering Quality System Audits and Inspections for Medical Devices" @default.
- W4386197814 cites W4200383194 @default.
- W4386197814 doi "https://doi.org/10.1007/978-3-031-22091-3_10" @default.
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