Quality assurance

Device manufacturers are obliged to follow quality assurance (QA) systems. Manufacturing facilities are subject to periodic inspection by government or accredited third party agencies. Manufacturers can meet QA requirements through certification to recognized standards, such as those developed by the International Organization for Standardization (ISO), in particular ISO 13485, which sets out quality systems standards for use in the regulation of medical devices. Quality system requirements can cover everything from initial design through to post-market vigilance. Quality assurance in the manufacturing process is often referred to as good manufacturing practice (GMP).

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