What is ISO 13485 Certification, what are the Steps and Benefits of it?
ISO 13485 Certification in Bahrain is Quality Management System requirements for regulatory functions represent the necessities that medical device manufacturers should incorporate into their management systems. this document supersedes its 1996 incarnation still as nut 46001, nut 46002, and ISO 13488. though supported by ISO 9001, ISO 13485 removes 9001's stress on continual improvement and client satisfaction. In its place, stress is on meeting regulatory still as client requirements, risk management, and maintaining effective processes.