![]() ![]() As a component of the regulatory ISO 13485 standard, a quality management system requires a systematic process for controlling, monitoring, and verifying, analyzing, and improving any activity or process that could affect product conformance. In the life and health sciences industry, quality management is a multidimensional and non-negotiable issue, covering more than just verification that a finished product meets certain expectations and is safe for use. ![]() ISO 13485:2016 Certification is vital for medical device organizations to demonstrate compliance with regulatory requirements so-called law of the land. ISO 13485 Certification provides a complete framework for medical device manufacturers, suppliers, or any other external party related to medical devices to ensure product quality and regulatory compliance with the standard.
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