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Japan Quality Audits 2009
Pacific Bridge Medical, Jan 2009, Pages: 35
Western medical device manufacturers that want to register and sell their products in Japan are now required to comply with Japan’s Quality Management System (QMS) standards. This Japan Quality Audits 2009 report is the only comprehensive English guide to the new Japanese quality audits, including official quality system requirements, documents needed, tips for success, and translations of key Japanese regulations.
The detailed information in this report will help your company pass the PMDA audit the first time. In some cases, QMS audits are conducted on paper only – however, on-site audits are becoming increasingly common, especially for riskier Class III and IV medical devices in Japan. This report is essential for any medical device company currently selling or considering selling their products in Japan’s $25 billion medical device market.
The report is 35 pages, plus an additional 61-page appendix.
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