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FSA 13485 (MEDICAL)

GENERAL PERSPECTIVE  ISO 13485:2003 is an international standard based on ISO 9001:2000 standard and it contains special requirements for medical devices. The standard covers quality management system requirements for a company expected to proove its capability of complying with requirements applicable to medical devices and related services with customer needs. The fundamental purpose of the standard is to facilitate the medical device regulation requirements harmonised for quality management systems.

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