Wow great find...
The US Food and Drug Administration (FDA), the government department that regulates the medical devices sector, announced its intention to use ISO 13485 as the basis for its quality system legislation.
Things may change rather quickly.
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- Ann: ResApp Clears Major Milestone for CE and TGA with ISO 13485
Ann: ResApp Clears Major Milestone for CE and TGA with ISO 13485, page-42
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