Tag Archives: MHLW MO 169

Devine Guidance

MHLW MO 169 – Chapter 2/Section 4 – Resource Management

By Dr. Christopher Joseph Devine

The key for successfully complying with MO 169 is not rooted in comprehending the similarities of the Japanese regulation to ISO 13485:2003, but in understanding, embracing, and complying with the differences.

The key for successfully complying with MO 169 is not rooted in comprehending the similarities of the Japanese regulation to ISO 13485:2003, but in understanding, embracing, and complying with the differences.

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Devine Guidance

MHLW MO 169 – Chapter Two: General Rules

By Dr. Christopher Joseph Devine

There’s just one takeaway from this week: If your organization already has a QMS premised on EN ISO 13485:2003, then you probably already comply. However, if your organization has identified design and development or product realization as excluded or not applicable within the Quality Manual, then it becomes; “Captain I think we have a problem!”

There’s just one takeaway from this week: If your organization already has a QMS premised on EN ISO 13485:2003, then you probably already comply. However, if your organization has identified design and development or product realization as excluded or not applicable within the Quality Manual, then it becomes; “Captain I think we have a problem!”

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