Sökning: "medical device regulation"
Visar resultat 1 - 5 av 17 uppsatser innehållade orden medical device regulation.
1. Hur MDR påverkar tillverkare av personlyftar och rullstolar - Standarder och upphandlingskrav
M1-uppsats, KTH/Medicinteknik och hälsosystemSammanfattning : Sedan 2021 regleras medicintekniska produkter inom EU av förordningen MDR (EU 2017/745). Det primära syftet med regelverket är att säkerställa ändamålsenliga produkter med hög säkerhet. Det nya regelverket ställer högre krav på företag som tillverkar medicintekniska produkter samt andra aktörer inom den medicintekniska industrin. LÄS MER
2. Utvärdering av kravspecifikation vid anskaffning av medicinsk teknik
Kandidat-uppsats, Lunds universitet/Avdelningen för Biomedicinsk teknikSammanfattning : All government controlled business is controlled by the law of public procurement and its five fundamental principles. If these are not fulfilled the procurement is at risk of being subject to a review procedure, which requires both time and money. LÄS MER
3. The Strategic Adoption of Additive Manufacturing in the orthopedic industry in Sweden
Master-uppsats, Uppsala universitet/Institutionen för samhällsbyggnad och industriell teknikSammanfattning : Additive Manufacturing (AM) is another name for rapid prototyping and 3D printing (3DP), an advanced manufacturing technology that creates 3D objects. AM's ability to produce complex shapes in industrial production is one of its chief advantages. LÄS MER
4. Design and Implementation of a Digital Traceability System of Implantable Pacemakers in the Care Process
Master-uppsats, KTH/Medicinteknik och hälsosystemSammanfattning : A major problem in healthcare today is the manual handling of administrative work. Few processes are automated and healthcare professionals are forced to spend a lot of time on paperwork, which means that their time with patients suffers. This has a major negative impact on patient safety. LÄS MER
5. Quality Management Systems in Healthcare : “Implementation of the Medical Device Regulation”
Master-uppsats, KTH/Skolan för industriell teknik och management (ITM)Sammanfattning : This study investigated how a QMS that is compliant with the Medical Device Regulation (MDR) can be constructed and what the most important aspects are when creating a functional QMS at a Swedish hospital. QMS:s are a fundamental part of a healthcare organization and are used to ensure safe and secure patient care. LÄS MER