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

MHLW MO 169 – Chapter 5 – Mutatis Mutandis

By Dr. Christopher Joseph Devine

…regulatory and quality compliance is premised on common sense, I repeat “common sense” then your organizations have been blessed with gifted professionals. For readers that remain unclear about the ramifications…

…regulatory and quality compliance is premised on common sense, I repeat “common sense” then your organizations have been blessed with gifted professionals. For readers that remain unclear about the ramifications…

Continue reading

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

MHLW MO 169 – Chapter 4 – Documents & Records

By Dr. Christopher Joseph Devine

…25, 2013, from https://www.federalregister.gov/articles/2013/01/22/2013-01068/current-good-manufacturing-practice-requirements-for-combination-products Linguanaut the Japanese phrases and expressions. (2012). Retrieved February 11, 2013, from http://www.linguanaut.com/english_japanese.htm Ministerial Ordinance 169. (2004). MHLW ministerial ordinance 169 on standards for manufacturing control…

…25, 2013, from https://www.federalregister.gov/articles/2013/01/22/2013-01068/current-good-manufacturing-practice-requirements-for-combination-products Linguanaut the Japanese phrases and expressions. (2012). Retrieved February 11, 2013, from http://www.linguanaut.com/english_japanese.htm Ministerial Ordinance 169. (2004). MHLW ministerial ordinance 169 on standards for manufacturing control…

Continue reading

Devine Guidance

MHLW MO 169 – Chapter 4 – Training

By Dr. Christopher Joseph Devine

systems – requirements for regulatory purposes (EN ISO 13485:2012). Final rule – cGMP requirements for combination products. (2013, January). FDA website. Retrieved January 25, 2013, from https://www.federalregister.gov/articles/2013/01/22/2013-01068/current-good-manufacturing-practice-requirements-for-combination-products Linguanaut the Japanese…

systems – requirements for regulatory purposes (EN ISO 13485:2012). Final rule – cGMP requirements for combination products. (2013, January). FDA website. Retrieved January 25, 2013, from https://www.federalregister.gov/articles/2013/01/22/2013-01068/current-good-manufacturing-practice-requirements-for-combination-products Linguanaut the Japanese…

Continue reading

Devine Guidance

MHLW MO 169 – Chapter 4 – Testing

By Dr. Christopher Joseph Devine

…ISO 13485:2012). Final rule – cGMP requirements for combination products. (2013, January). FDA website. Retrieved January 25, 2013, from https://www.federalregister.gov/articles/2013/01/22/2013-01068/current-good-manufacturing-practice-requirements-for-combination-products Linguanaut the Japanese phrases and expressions. (2012). Retrieved February 2,…

…ISO 13485:2012). Final rule – cGMP requirements for combination products. (2013, January). FDA website. Retrieved January 25, 2013, from https://www.federalregister.gov/articles/2013/01/22/2013-01068/current-good-manufacturing-practice-requirements-for-combination-products Linguanaut the Japanese phrases and expressions. (2012). Retrieved February 2,…

Continue reading

Devine Guidance

MHLW MO 169 – Chapter 4 – Process Control

By Dr. Christopher Joseph Devine

…EU or the United States, MHLW is big on having device manufacturers that make medical devices that contain a component of biological-origin or cell/tissue component, keeping meticulous record. Nobody wants…

…EU or the United States, MHLW is big on having device manufacturers that make medical devices that contain a component of biological-origin or cell/tissue component, keeping meticulous record. Nobody wants…

Continue reading

Devine Guidance

MHLW MO 169 – Chapter 4 – Manufacturing Control & Quality Control

By Dr. Christopher Joseph Devine

…management systems – requirements for regulatory purposes (EN ISO 13485:2012). Linguanaut the Japanese phrases and expressions. (2012). Retrieved September 8, 2012, from http://www.linguanaut.com/english_japanese.htm.  Ministerial Ordinance 169. (2004). MHLW ministerial ordinance…

…management systems – requirements for regulatory purposes (EN ISO 13485:2012). Linguanaut the Japanese phrases and expressions. (2012). Retrieved September 8, 2012, from http://www.linguanaut.com/english_japanese.htm.  Ministerial Ordinance 169. (2004). MHLW ministerial ordinance…

Continue reading

Devine Guidance

MHLW MO 169 – Chapter 4 – Infrastructure

By Dr. Christopher Joseph Devine

…biological-origin. Never take anything to chance when it comes to conveying the importance of handling, processing, or storing devices containing a component of biological-origin. Why? Because. Because why Dr. D?…

…biological-origin. Never take anything to chance when it comes to conveying the importance of handling, processing, or storing devices containing a component of biological-origin. Why? Because. Because why Dr. D?…

Continue reading

Devine Guidance

MHLW MO 169 – Chapter 3 – Control of Documents & Records

By Dr. Christopher Joseph Devine

…phrases and expressions. (2012). Retrieved September 8, 2012, from http://www.linguanaut.com/english_japanese.htm Ministerial Ordinance 169. (2004). MHLW ministerial ordinance 169 on standards for manufacturing control and quality control for medical devices and…

…phrases and expressions. (2012). Retrieved September 8, 2012, from http://www.linguanaut.com/english_japanese.htm Ministerial Ordinance 169. (2004). MHLW ministerial ordinance 169 on standards for manufacturing control and quality control for medical devices and…

Continue reading

Devine Guidance

MHLW MO 169 – Chapter 3 – Training

By Dr. Christopher Joseph Devine

…to know Implementation of a compliant training program is a relatively easy task (Dr. D’s opinion) so how come far too many organizations fail to succeed? One of the pitfalls…

…to know Implementation of a compliant training program is a relatively easy task (Dr. D’s opinion) so how come far too many organizations fail to succeed? One of the pitfalls…

Continue reading

Devine Guidance

MHLW MO 169 – Chapter 3 – Internal Audit

By Dr. Christopher Joseph Devine

…Website. Retrieved November 29, 2012, from http://www.emergogroup.com/services/japan/device-master-file-japan EN ISO 13485:2012. (2012, February). Medical devices – quality management systems – requirements for regulatory purposes (EN ISO 13485:2012). Linguanaut the Japanese phrases…

…Website. Retrieved November 29, 2012, from http://www.emergogroup.com/services/japan/device-master-file-japan EN ISO 13485:2012. (2012, February). Medical devices – quality management systems – requirements for regulatory purposes (EN ISO 13485:2012). Linguanaut the Japanese phrases…

Continue reading