Tag Archives: Japanese medical device regulations

Dr. Christopher Joseph Devine, President, Devine Guidance International
Devine Guidance

MHLW MO 169 – Chapter 2/Section 6 – Monitoring of Processes, Products, and Specialty Medical Devices

By Dr. Christopher Joseph Devine
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Dr. Christopher Joseph Devine, President, Devine Guidance International

It is not enough for device manufacturers to simply clone a QMS or develop procedures employed for device manufacturing. Manufacturers must be able to gauge the effectiveness of their policies, procedures and processes, and provide objective evidence that their approach to quality and the manufacturing of devices is effective.

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