ISO 13485

Since 2000, many nations have begun to conduct ISO 13485 quality systems as a fundamental framework for such directives as the European medical device directive, active implantable medical device directive and in-vitro diagnostic device directive, as well as standards for good manufacturing practices (GMP) and others. ISO 13485 covers a wide range of essential requirements, risk analysis/assessment, clinical evaluation/investigation, labeling, technical standards, information feedback system, post-market surveillance, customer complaint investigation, vigilance system and advisory notice. At present, a lot of countries use the standard to examine imported products.

TÜV Rheinland can assist manufacturers to obtain ISO 13485 certificates, which will be beneficial to international marketing.