ISO 13485 is an ISO standard that establishes requirements for medical device manufacturer’s quality management systems. On January 1, 2016, ISO released the newest version of this standard, ISO 13485:2016.
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CE certification is a process of assessing and certifying products to meet the European Union’s health, safety, and environmental protection standards.
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ISO 13485 is the ISO standard that specifies requirements for a comprehensive quality management system for manufacturers of medical devices.
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HACCP stands for Hazard Analysis and Critical Control Point. HACCP is a system that identifies critical points in the production chain at which controls can be applied to prevent or eliminate contamination by pathogens, including bacteria, viruses, parasites and other microorganisms.
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The international standard ISO 27001 defines requirements for the Information Security Management System’s (ISMS) continuous improvement.
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