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ISO Management Standards for Medical Devices

Two main ISO standards that have a direct application to Medical Device Industry are ISO 9001 and ISO 13485.

While ISO 9001 is for evolving a Quality Management System for an organization, ISO 13485 has a direct application to Medical Device Industry.

Although, ISO standards for a company are not a legal requirement, but provide a validation and ease of global marketing of the product.

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  1. Jaya Pandey, Ph.D., SCPMDecember 8, 2009 at 8:02 PM

    Thanks David for browsing through our Blogs. More to follow on the same topic.

    Sincerely

    Jaya

    ReplyDelete

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