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ISO 134845:2005 is a management system standard developed exclusively for medical devices manufacture. This certification procedure in , India improves the efficiency of the company and thus helps in generating profits in , India. ISO 13485 plays an essential role for any organization in , India operating in the medical device and pharmaceutical supply chain. For achieving the ISO 13485:2005 Certification in , India an organization needs to exhibit its capability to offer medical devices and related services that without fail meet customer requirements in , India and regulatory requirements in , India. The chief objective of ISO 13485 is to assist with harmonized medical device regulatory requirements in , India. ISO 13485 excludes few requirements of ISO 9001 and includes some particular requirements in , India for medical devices. An organization in , India after achieving ISO 13485 Certification of International Standard cannot claim conformity to ISO 9001 because of exclusions of few requirements. Regardless of the type or size of the organization, all requirements of ISO 13485:2005 are particularly made for medical based organizations in , India. What benefits does ISO 13485 Certification
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