Implementation of risk management activities within a quality management system. An osseous adhesive as case study

Abstract

Medical device regulatory agencies have adopted quality and risk management approaches to demonstrate compliance with the essential principles of safety and performance. For this reason, specific standards are established in the medical device sector for the quality management system by regulatory purposes and a systematic process, in order to minimize risks throughout the life-cycle of the product. The objectives of this paper are to show how the risk management process can be inserted into the product design/development strategy within a quality management system and to apply such strategy to an osseous adhesive as a case study. Integration of a risk management system within a QMS can be an advantage for manufacturers of medical devices in order to comply with regulatory requirements. At the design and development stages the risk management principles should be applied and used to identify and address safety issues and to plan risk control activities. The risk assessment conducted shows that the Wollastonite/n-butyl-2-cyanoacrylate adhesive composite is safe by design. Adequate labeling and operating instructions have to be incorporated to the final product to minimize the risks or improper usage and storage outside prescribed environmental conditions. In addition, validation and control measures of the sterilization process and packaging have to be taken to maintain the acceptable levels for all identified risks.