Tag Archives: Devine Guidance

Devine Guidance

MHLW MO 169 – Chapter Two – Quality Management System

By Dr. Christopher Joseph Devine

There are two takeaways this week: One, if you have not commenced with building a requirements matrix for your organization, stop the procrastination and start building the matrix, today. And two, ensure specific regulatory requirements find their way into your procedures.

There are two takeaways this week: One, if you have not commenced with building a requirements matrix for your organization, stop the procrastination and start building the matrix, today. And two, ensure specific regulatory requirements find their way into your procedures.

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Devine Guidance

MHLW MO 169 – Chapter One

By Dr. Christopher Joseph Devine

Chapter one of MO 169 establishes the foundation needed for manufacturers to gain entry into the Japanese market for their products. Complying with all of the requirements delineated throughout MO 169 is not only the expectation, it is mandated by law.

Chapter one of MO 169 establishes the foundation needed for manufacturers to gain entry into the Japanese market for their products. Complying with all of the requirements delineated throughout MO 169 is not only the expectation, it is mandated by law.

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Devine Guidance

MHLW Ministerial Ordinance 169

By Dr. Christopher Joseph Devine

There are so many tiny idiosyncrasies associated with regulatory compliance in Japan it is difficult to choose a place where to start the journey toward complying with all of the requirements.

There are so many tiny idiosyncrasies associated with regulatory compliance in Japan it is difficult to choose a place where to start the journey toward complying with all of the requirements.

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

Introduction to the Japanese Medical Device Market

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

Well (deep subject, the doctor knows), I know many of the readers were wondering about Dr. D’s next series. The doctor really wanted to make this next series an enjoyable surprise. That being said, surprise, surprise, surprise (thank you Gomer Pyle USMC); the next series of Dr. D’s articles will be focused on complying with MHLW Ministerial Ordinance Number 169.

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

IVDD Epilogue

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

During the course of the last eight months, Dr. D has had the opportunity to dive into 98/79/EC, the European In-Vitro Diagnostic Medical Device Directive while extracting salient elements in the hope of providing Devine Guidance for the readers. This journey has now come to an end.

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Devine Guidance

IVDD Annex IX

By Dr. Christopher Joseph Devine

The relationship between the notified body and the device manufacturer is not unlike a marriage. If a positive relationship is garnered and sustained, life is beautiful. If the relationship sours, then divorce is inevitable; and then the phrase is; “I want my CE mark back, now!”

The relationship between the notified body and the device manufacturer is not unlike a marriage. If a positive relationship is garnered and sustained, life is beautiful. If the relationship sours, then divorce is inevitable; and then the phrase is; “I want my CE mark back, now!”

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Devine Guidance

IVDD Annex VIII

By Dr. Christopher Joseph Devine

This week’s guidance for IVDD Annex VII reiterates a device manufacturer’s commitment to supplying a device capable of providing accurate and repeatable results and ongoing compliance with the Directive.

This week’s guidance for IVDD Annex VII reiterates a device manufacturer’s commitment to supplying a device capable of providing accurate and repeatable results and ongoing compliance with the Directive.

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Devine Guidance

IVDD Annex VI (EC Verification)

By Dr. Christopher Joseph Devine

Two takeaways this week are immensely important for device manufacturers: 1. Make sure maximum effort is exuded during the documenting and validation of the manufacturing processes, and 2. Manufacturers must take an active part in determining appropriate sample sizes for verification testing; do not let notified bodies make this decision without your input.

Two takeaways this week are immensely important for device manufacturers: 1. Make sure maximum effort is exuded during the documenting and validation of the manufacturing processes, and 2. Manufacturers must take an active part in determining appropriate sample sizes for verification testing; do not let notified bodies make this decision without your input.

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