Research and Markets: Japan Quality Audits Report 2009 Helps your Company Pass its PMDA Audit the First Time

DUBLIN, Ireland--(BUSINESS WIRE)--Research and Markets (http://www.researchandmarkets.com/research/fa2bf7/japan_quality_audi) has announced the addition of the "Japan Quality Audits Report 2009" report to their offering.

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.

Key Topics Covered:

Introduction

Registration Overview

• Registration system
• Audits and how they fit into registration

Foreign Manufacturer Accreditation (FMA)

• Overview and scope of FMA
• Categorization of devices under FMA
• Documents to submit for FMA
• Application and review process
• Changes or additions

QMS Compliance Audit

• Introduction
• General information
• Determination of on-site vs. paper audit
• Paper audit details
• On-site audit details
• QMS renewal

V. Interacting Successfully with Japanese Auditors

• Introduction
• Cultural principles
• Auditor mindset
• Business etiquette
• During an on-site audit
• Logistical issues for on-site audit

Conclusion

Appendices

For more information visit http://www.researchandmarkets.com/research/fa2bf7/japan_quality_audi