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.