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Since 2000, many nations have begun to conduct ISO 13485/88 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 13485/88 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 13485/88
certificates, which will be beneficial to international marketing.
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