Tag Archives: MHLW MO 169

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
No Comments
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.

Continue reading

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

MHLW MO 169 – Chapter 2/Section 5 – Customer Property & Preservation of Products

By Dr. Christopher Joseph Devine
No Comments
Dr. Christopher Joseph Devine, President, Devine Guidance International

Although customer property and the management and handling of customer-supplied material is not important for FDA, that is clearly not the case for MHLW. And, preservation of products is important in all regulatory environments, so create a robust SOP with sufficient granularity to address all Article 52 requirements.

Continue reading

Devine Guidance

MHLW MO 169 Chapter 2/Section 5 – Design and Development

By Dr. Christopher Joseph Devine
No Comments

Medical devices that are safe and effective are rooted in a robust design and it is impossible to design a medical device that is safe and effective, in its intended use, without the establishment of a well-documented design and development process.

Medical devices that are safe and effective are rooted in a robust design and it is impossible to design a medical device that is safe and effective, in its intended use, without the establishment of a well-documented design and development process.

Continue reading

Devine Guidance

MHLW MO 169 Chapter 2/Section 5 – Product Realization

By Dr. Christopher Joseph Devine
No Comments

“Failing to properly plan is a plan for failure”—truer words could not have been written when it comes to the design and manufacture of medical devices that are safe and effective.

“Failing to properly plan is a plan for failure”—truer words could not have been written when it comes to the design and manufacture of medical devices that are safe and effective.

Continue reading