About ISO 13485:2016 Certification
ISO 13485: 2016 specifies the requirements for a quality management system when an organization has to demonstrate its ability to provide medical devices and related services that consistently meet customer requirements and regulatory requirements applicable to medical devices and Carry out related services. Most regulators in the global medical device market require manufacturers to implement quality management systems (QMS) as part of their product registration efforts. In most countries, ISO 13485 certification is the preferred or required method to meet QMS requirements.
What is ISO 13485?
ISO 13485 Medical Device - Quality Management System - Requirements for regulatory purposes is a standard of the International Organization for Standardization (ISO) first published in 1996; It represents the requirements of a complete quality management system for the design and manufacture of medical products.
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