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ISO 13485

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ISO 13485, an international standard, sets out the prerequisites for the medical device sector. It is designed for use by companies throughout the entire life cycle of medical devices, encompassing production, post-production, and even decommissioning and disposal stages.

Additional information

ISO 13485

ISO 13485 Lead Implementer (English), ISO 13485 Lead Implementer (French), ISO 13485 Lead Auditor (English), ISO 13485 Foundation (English)

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