This document discusses the criteria for selecting medical devices, including regulatory compliance, intended use, clinical performance, cost-effectiveness, technical specifications, manufacturer reputation, and maintenance/support. Medical devices must comply with regulations, be appropriate for their intended use and patient population, demonstrate safety and effectiveness through clinical testing, have a balanced cost and benefits, meet technical requirements, and be supported by a reputable manufacturer providing maintenance. Careful consideration of these criteria can help ensure medical devices are safe, effective and high quality.
This document discusses the criteria for selecting medical devices, including regulatory compliance, intended use, clinical performance, cost-effectiveness, technical specifications, manufacturer reputation, and maintenance/support. Medical devices must comply with regulations, be appropriate for their intended use and patient population, demonstrate safety and effectiveness through clinical testing, have a balanced cost and benefits, meet technical requirements, and be supported by a reputable manufacturer providing maintenance. Careful consideration of these criteria can help ensure medical devices are safe, effective and high quality.
Original Title
Lecture6 Introduction to Medical Devices Management
This document discusses the criteria for selecting medical devices, including regulatory compliance, intended use, clinical performance, cost-effectiveness, technical specifications, manufacturer reputation, and maintenance/support. Medical devices must comply with regulations, be appropriate for their intended use and patient population, demonstrate safety and effectiveness through clinical testing, have a balanced cost and benefits, meet technical requirements, and be supported by a reputable manufacturer providing maintenance. Careful consideration of these criteria can help ensure medical devices are safe, effective and high quality.
This document discusses the criteria for selecting medical devices, including regulatory compliance, intended use, clinical performance, cost-effectiveness, technical specifications, manufacturer reputation, and maintenance/support. Medical devices must comply with regulations, be appropriate for their intended use and patient population, demonstrate safety and effectiveness through clinical testing, have a balanced cost and benefits, meet technical requirements, and be supported by a reputable manufacturer providing maintenance. Careful consideration of these criteria can help ensure medical devices are safe, effective and high quality.
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MANAGEMENT OF
MEDICAL DEVICES SELECTED TOPICS IN BIOMEDICAL ENGINEERING (BM5922)
BIOMEDICAL ENGINEERING , SAMS, GJU
2ND 2022-2023 SELECTION CRITERIA FOR MEDICAL DEVICES INTRODUCTI •THE CRITERIA THAT SHOULD BE CONSIDERED WHEN SELECTING MEDICAL DEVICES TO ENSURE THAT THEY ON: ARE SAFE, EFFECTIVE, AND OF HIGH QUALITY. REGULATOR • THE FIRST CRITERIA TO CONSIDER IS REGULATORY COMPLIANCE. MEDICAL DEVICES MUST COMPLY WITH Y LOCAL AND INTERNATIONAL REGULATIONS AND COMPLIANC STANDARDS. THEY MUST BE APPROVED BY REGULATORY
E: BODIES AND HAVE PROPER DOCUMENTATION OF THEIR
REGULATORY COMPLIANCE. INTENDED USE THE •IT IS IMPORTANT TO CONSIDER WHETHER THE MEDICAL INTENDED DEVICE IS APPROPRIATE FOR THE INTENDED USE AND THE
USE OF THE PATIENT POPULATION. THIS INCLUDES THE CLINICAL
INDICATION, ANATOMICAL LOCATION, AND THE MEDICAL INTENDED PATIENT POPULATION.
DEVICE: CLINICAL PERFORMAN •THIS INCLUDES THE SAFETY, EFFECTIVENESS, AND CE THE EFFICIENCY OF THE MEDICAL DEVICE. IT IS IMPORTANT CLINICAL TO CONSIDER WHETHER THE MEDICAL DEVICE HAS BEEN PERFORMAN CLINICALLY TESTED AND VALIDATED.
CE: COST- EFFECTIVENE • THE COST OF THE MEDICAL DEVICE MUST BE BALANCED
SS COST- AGAINST ITS BENEFITS. IT IS IMPORTANT TO CONSIDER
THE TOTAL COST OF OWNERSHIP, INCLUDING THE COST EFFECTIVENE OF MAINTENANCE, TRAINING, AND DISPOSAL. SS: TECHNICAL SPECIFICATION •THIS INCLUDES THE DESIGN, FEATURES, AND FUNCTIONALITY OF THE MEDICAL DEVICE. IT IS S THE IMPORTANT TO CONSIDER WHETHER THE MEDICAL TECHNICAL DEVICE MEETS THE TECHNICAL SPECIFICATIONS SPECIFICATION OUTLINED IN THE TENDER. S: MANUFACTUR ER REPUTATION • IT IS IMPORTANT TO CONSIDER THE MANUFACTURER'S THE HISTORY, EXPERIENCE, AND TRACK RECORD IN REPUTATION DEVELOPING AND PRODUCING MEDICAL DEVICES. OF THE MANUFACTUR ER: MAINTENAN CE AND • IT IS IMPORTANT TO CONSIDER WHETHER THE SUPPORT MANUFACTURER PROVIDES SUPPORT FOR THE MEDICAL MAINTENAN DEVICE, INCLUDING TRAINING, TECHNICAL SUPPORT,
CE AND AND REPAIR SERVICES.
SUPPORT: • IN CONCLUSION, THE SELECTION OF MEDICAL DEVICES REQUIRES CAREFUL CONSIDERATION OF MULTIPLE CRITERIA TO ENSURE THAT THEY ARE SAFE, EFFECTIVE, CONCLUSIO AND OF HIGH QUALITY. THESE CRITERIA INCLUDE N: REGULATORY COMPLIANCE, INTENDED USE, CLINICAL PERFORMANCE, COST-EFFECTIVENESS, TECHNICAL SPECIFICATIONS, MANUFACTURER REPUTATION, AND MAINTENANCE AND SUPPORT.
