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- Title
QSV - was ist das denn? Korrekte Herstellung von Medizinprodukten über eine Qualitätssicherungsvereinbarung regeln.
- Authors
STRIETZEL, ROLAND
- Abstract
A Quality Assurance Agreement (QAA) is an agreement between a supplier and a customer that defines all measures for ensuring the quality of products, services, and performances. Dental laboratories often use external manufacturing centers as service providers for individually manufactured parts. A QAA is used to ensure that all manufacturing processes meet the requirements. The article describes the importance of a Quality Assurance Agreement (QAA) in relation to the Medical Device Regulation (MDR). A QAA includes general requirements for the production process, market surveillance, risk management, and personnel management. Key requirements of the MDR are post-market surveillance of a medical device and reporting of reportable events to authorities. The article also describes the importance of manufacturer audits and Quality Assurance Agreements (QAA) for companies. A QAA can deeply impact the quality management system and therefore requires careful preparation.
- Subjects
MEDICAL equipment; INDUSTRIAL safety; QUALITY assurance; DENTAL equipment; PERSONNEL management; CHEMICAL laws; PRODUCT quality; DENTAL laboratories; MANUFACTURING processes; TOTAL quality management; DIGITAL technology
- Publication
Quintessenz der Zahntechnik, 2022, Vol 48, Issue 5, p540
- ISSN
0340-4641
- Publication type
Article