To ensure the safety for both patients and personnel using medical equipment there are several regulations. The regulations differ between countries and the largest markets are the US and Europe. There are regulations regarding both risk and requirement management and for a digitized signature process. This report shows a way of digitizing parts of the quality management system and workflows that fulfills these requirements, including both an approval process and a requirement hierarchy. For the development of a digitized system several workshops and interviews were performed to understand the workflow used. This to reduce the changes in the new system where the existing processes worked, but at the same time make changes possible where the users noticed problems in the workflow earlier used. The main advantage of a digitized quality management system is that the linking between the different objects are easier to follow which gives a perspicuous traceability. A digitized system can generate reports, e.g. for traceability and requirement without a test, automatically that will decrease the manual work and by that both increase efficiency and reduce the risk of human errors.
| Identifer | oai:union.ndltd.org:UPSALLA1/oai:DiVA.org:kth-279142 |
| Date | January 2020 |
| Creators | Lundkvist, Andrea |
| Publisher | KTH, Medicinteknik och hälsosystem |
| Source Sets | DiVA Archive at Upsalla University |
| Language | English |
| Detected Language | English |
| Type | Student thesis, info:eu-repo/semantics/bachelorThesis, text |
| Format | application/pdf |
| Rights | info:eu-repo/semantics/openAccess |
| Relation | TRITA-CBH-GRU ; 2020:084 |
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