Iso 13485 logo10/16/2023 ![]() ![]() ISO/IEC 13485: 2003 represents the management system requirements for companies that want to maintain compliance with medical device regulations. The medical device industry is expected to grow 4.6% through 2011, despite the worldwide financial crisis. ![]() The inherent nature of these products has implications for the health and safety of the people who use them.Īs the median age and the percentage of the population over 65 continues to grow, the need for medical devices will continue to increase. Consumers are becoming more educated about the safety and efficacy of medical devices. ![]() In an ever-shrinking world, the need for regulatory harmonization and quality assurance has become increasingly important.
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