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3.13 Quality audit means a systematic, independent examination of a manufacturer's quality...

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6.0 Resource management 6.1 Provision of resources The manufacturing organization shall de...

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3.8 Design output means the results of a design effort at each design phase and at the end...

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9.0 Analytical performance characteristics: 9.1 Accuracy of measurement: This section shou...

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Design and development review: At suitable stages, systematic reviews of design and develo...

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Medical Doctor (MD) License: Medical doctors, also known as physicians or doctors of medic...

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7.3.4 Design and development review: At suitable stages, systematic reviews of design and ...

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3.18.2 Design validation means establishing by objective evidence that device specificatio...

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3.16 Rework means action taken on a non-conforming product that will fulfill the specified...

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