University Ss Cyril and Methodius in Skopje, Faculty of Pharmacy and Macedonian Pharmaceutical Association
Abstract
The importance of medical devices in everyday users/patients lives is imensse. This is the reason why emphasis must be put on safety
during their use. Satisfactory safety level can be achived by implementation of quality and risk management standards. Medical device manufacturers must learn to deal with the potential risks by using theoretical and practical examples and measures in order to protect their users/patients and themselves from suffering huge losses arising from adverse events or recall of their products. The best moment for implementation of risk management methods and analysis begins from the device design and development through manufacturing, sales and distribution. These way medical device manufacturers will succseed in protecting their users/patients from serious adverse events and at the same time protect their brand and society status, while minimizing economic losses