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Japan Quality Audits Report 2009
Pacific Bridge Medical, Jan 2009, Pages: 35
Don’t get caught with your pants down! Prepare for Japanese medical device audits
Recently, Western medical device manufacturers have had to comply with Japan’s Quality Management System (QMS) standards to register and sell their products in Japan. This new 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.
Help your company pass its PMDA audit the first time with this comprehensive report. The report is 35 pages, plus an additional 61-page appendix.
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