Address:  Suite A-26-03, Block A, I Soho @ I City, 

     Persiaran Multimedia,

     Section 7, 40000 Shah Alam,

     Selangor Darul Ehsan

Phone:    03-5870 2188 / 03- 5870 2188

Mobile:    019-655 0744 / 016 - 688 0744

Fax:        03-5870 2188


© 2012 by Business Solutions.

ISO 13485

ISO 13485 - A specific quality management system for Medical Device manufacturer


This standard is recognized by most major markets around the world (United States of America,Europe, Canada, Japan, and Australia) and more major markets are likely to adopt this standard. With ISO 13485 certification you will be able to enter any major market around the world withone audit. By becoming ISO 13485 certified your company’s Quality Management System(QMS) will be in line with the Food a nd Drug Administration’s (FDA) QSR standards

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