Titlebook: Medical Devices and In Vitro Diagnostics; Requirements in Euro Christian Baumgartner,Johann Harer ,Jörg Schröttne Living reference work 202

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Mastering Quality System Audits and Inspections for Medical Devices,fy 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

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Quality Management Requirements in Compliance with European Regulations,ment system of medical device and in vitro diagnostic manufacturers. The extent to which the EN ISO 13485 meets the requirements of the new EU regulations for medical devices and in vitro diagnostics is discussed. The basics of a quality management system, the responsibility of the management, resou

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Validation of Methods and Analytical Processes for In Vitro Diagnostics, are tightly interlinked. In method development, analysis techniques and steps are defined that are later applied in method validation..A key question is: When is it necessary to validate or revalidate analytical methods? The answer is:.Numerous committees and publications have discussed and explain

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Manufacturing and Quality Assurance in Compliance with the MDR and IVDR,teria are achieved with a high probability during series production. In particular, this chapter describes how tests are to be carried out in the incoming goods, the process, and the final inspection department, which records are required in production, and how the current product status can be mark

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Post-Market Surveillance and Vigilance on the European Market,ative environment contribute to the fact that a product initially approved as “safe and effective” leads to complaints, to malfunctions, and, in the worst case, to a safety risk for users, patients, or the general public. For this reason, it is necessary that manufacturers of medical devices and in