MEDICAL DEVICE MANUFACTURER - 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