Our consulting company to support establishment and maintenance to quality management system for medical device manufacturer. The manufacturer should comply to
requirements and regulations with their quality management system. Important of the system is to have effective and good practice, therefore that is needed a support with an experience, insight
and knowledge. Our consulting to be able to provide,- seminar or publishing of valuable information for clear understanding of
- preparing to certification audit, FDA inspection (train convincing and logical thinking, mock audit)
- instructor for complaint/MDR handling, CAPA, design validation, process validation and etc
- coaching for quality improvement (process kaizen, quality control, 5S and etc) practically.
Through such support, our company hope that we could realize that medical device manufacturing improving to more high performance.
Support to Japanese
manufacturer challenging to world class player of medical device industry
Target to achieve compatibility both of Japanese manufacturing and US common standards of medical device compliance
Through faithful and passionately consulting activities, that endeavor to realize solutions that will lead to improvements to higher quality management system
AQUASYS Consultants Corp.
Sunny Heights 303
Nishiki-cho 1- 4 - 4
Tachikawa, Tokyo, Japan