LEADER 05734nam 22007575 450 001 9910766896203321 005 20231126164840.0 010 $a3-031-43444-7 024 7 $a10.1007/978-3-031-43444-0 035 $a(MiAaPQ)EBC30974058 035 $a(Au-PeEL)EBL30974058 035 $a(DE-He213)978-3-031-43444-0 035 $a(EXLCZ)9929084008500041 100 $a20231126d2024 u| 0 101 0 $aeng 135 $aurcnu|||||||| 181 $ctxt$2rdacontent 182 $cc$2rdamedia 183 $acr$2rdacarrier 200 10$aInspection of Medical Devices$b[electronic resource] $eFor Regulatory Purposes /$fedited by Almir Badnjevi?, Mario Cifrek, Ratko Magjarevi?, Zijad D?emi? 205 $a2nd ed. 2024. 210 1$aCham :$cSpringer Nature Switzerland :$cImprint: Springer,$d2024. 215 $a1 online resource (441 pages) 225 1 $aSeries in Biomedical Engineering,$x1864-5771 311 08$aPrint version: Badnjevi?, Almir Inspection of Medical Devices Cham : Springer,c2024 327 $aIntroduction -- Regulations and directives-Past, Present, Future -- Legal metrology system-Past, Present, Future -- Medical Device maintenance regimes in healthcare institutions -- Post-Market Surveillance (PMS) of Medical Devices: From a Clinical Engineering Perspective -- Application of Artificial Intelligence for management of maintenance and prediction of performances -- Inspection and Testing of Electrocardiographs (ECG) Devices -- Inspection and Testing of Noninvasive Blood Pressure Measuring Devices -- Inspection and Testing of Diagnostic Ultrasound Devices -- Inspection and Testing of Electroencephalographs, Electromyographs, and Evoked Response Equipment -- Inspection and Testing of Defibrillators -- Inspection and Testing of Mechanical Ventilators and Anaesthesia Machines -- Inspection and Testing of Pediatric and Neonatal Incubators -- Inspection and Testing of Infusion Pumps -- Cost Effectiveness analysis of medical devices in legal metrology system -- Cybersecurity, Data Protection, and Artificial Intelligence in Medical Devices. 330 $aThis comprehensive guide invites nations worldwide to embark on a transformative journey, implementing independent third-party verification systems that ensure medical devices comply with both international and national regulations. Prepare to be captivated as we delve into the intricate processes, unveil essential procedures, and illuminate the paramount importance of establishing traceability for medical device measurements. Imagine a world where medical devices undergo rigorous independent safety and performance verification, guaranteeing the utmost reliability for patient diagnoses and treatment. This book takes you on a compelling exploration of precisely that vision. Focusing on cutting-edge diagnostic and therapeutic devices, it captures the very essence of the latest international directives and regulations, ensuring you stay ahead of the curve. This new edition goes beyond the conventional, delving into the realms of innovation and progress. Unveiling in-depth maintenance regimes within healthcare institutions, we provide you with invaluable insights into post-market surveillance. As the world embraces the transformative potential of artificial intelligence, we pave the way for evidence-based management of medical device maintenance?a concept poised to reshape the healthcare landscape. Imagine a future where medical devices are seamlessly integrated into the legal metrology system, while fully operational national laboratories for medical device inspection set new standards of excellence. This book vividly illustrates how such a powerful union can elevate the reliability of medical devices in diagnosis and patient care. Brace yourself for a paradigm shift that not only enhances efficacy but also leads to significant cost reductions within your country's healthcare system. Join us on this extraordinary journey as we unveil the untapped potential of medical device inspection. With our innovative approach and unrivaled expertise, together we can revolutionize healthcare, transforming the lives of countless patients worldwide. Get ready to be inspired, informed, and empowered?welcome to the future of healthcare! 410 0$aSeries in Biomedical Engineering,$x1864-5771 606 $aBiomedical engineering 606 $aMedical physics 606 $aMeasurement 606 $aMeasuring instruments 606 $aSolid state physics 606 $aMedical laws and legislation 606 $aSecurity systems 606 $aBiomedical Engineering and Bioengineering 606 $aMedical Physics 606 $aMeasurement Science and Instrumentation 606 $aElectronic Devices 606 $aMedical Law 606 $aSecurity Science and Technology 615 0$aBiomedical engineering. 615 0$aMedical physics. 615 0$aMeasurement. 615 0$aMeasuring instruments. 615 0$aSolid state physics. 615 0$aMedical laws and legislation. 615 0$aSecurity systems. 615 14$aBiomedical Engineering and Bioengineering. 615 24$aMedical Physics. 615 24$aMeasurement Science and Instrumentation. 615 24$aElectronic Devices. 615 24$aMedical Law. 615 24$aSecurity Science and Technology. 676 $a610.28 700 $aBadnjevi?$b Almir$01450044 701 $aCifrek$b Mario$01450045 701 $aMagjarevi?$b Ratko$01438398 701 $aD?emi?$b Zijad$01450046 801 0$bMiAaPQ 801 1$bMiAaPQ 801 2$bMiAaPQ 906 $aBOOK 912 $a9910766896203321 996 $aInspection of Medical Devices$93648887 997 $aUNINA