IMPACT OF APPLYING INTERNATIONAL QUALITY STANDARDS ON MEDICAL EQUIPMENT IN SAUDI ARABIA

With the great development that, modern medical technology is witnessing today, medical devices and equipment have become a basic pillar of any healthcare system in the world and cannot be dispensed with, so we find competition between the major companies that manufacture medical devices and equipment resulting in a huge variety of complex modern medical technologies. These medical devices and equipment require high accuracy in manufacturing and packaging in addition to operation, maintenance, and followup, because any error in any of the previous stages will have bad consequences for the patients and the health system, there are many accidents that have led to some deaths. Therefore, we find that many medical device producers and medical companies in addition to health service providers seek to find systems and protocols to reduce accidents resulting from medical devices. As a result, many systems have recently appeared that seek to protect from the dangers of medical devices and equipment. This research aims to conduct a study of the effects of international standards on the safety of medical devices and equipment and reduce their risks. By counting the international standards in force in the Kingdom of Saudi Arabia that are applied by the Saudi Food and Drug Authority, making questionnaires, and distributing them to health service providers and regulatory bodies for medical devices and equipment, considering the data, these data will be analysed and evaluated the effectiveness of quality systems and standards in maintaining Effectiveness and quality of medical devices and equipment. The study will include governmental and private health services sectors.