Tag Archives: quality systems management

Devine Guidance

MHLW MO 169 – Chapter 4 – Infrastructure

By Dr. Christopher Joseph Devine
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The Japanese regulatory authorities take seriously the need to adequately identify and control medical devices that contain a biological-origin component, requiring establishment and validation of a cleanroom/controlled environment for manufacturing activities.

The Japanese regulatory authorities take seriously the need to adequately identify and control medical devices that contain a biological-origin component, requiring establishment and validation of a cleanroom/controlled environment for manufacturing activities.

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