Cultural Diversity - New Challenge to Medical Device Use Safety for International Markets

摘要

Medical device nowadays may be used by user groups with quite different cultural backgrounds. Cultural diversity may influence normal medical device use or even induce risks and hazards. Manufacturers are facing up to a new challenge to consider cultural diversities in design. This paper aims to formulate a systematic framework to handle medical device design for international markets. The standardized requirement specified in risk management standard of ISO 14971 is adopted as a basis. The cultural diversities that may induce risks and hazards are summarized. Medical device design issues that should be adapted are discussed. Many examples on these issues are presented.