Iso 13485 certification
Iso 13485 certification iso#
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Iso 13485 certification verification#
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The certification process consists of 3 basic phases:ģ) Certification by an accredited certification body The standard contains the requirement for quality management systems, to meet customer requirement and incorporate applicable regulatory requirements within an organization’s quality management system. ISO 13485 is applicable to designers, manufacturers, and distributors of medical devices.
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ISO 13485 is Quality Management System for Medical Devices.