Devine Guidance

Not all Suppliers Need Audits

By Dr. Christopher Joseph Devine

…13485 Certificates; Lead Auditor Certificate; Resume, etc., are acceptable in lieu of survey. • Standard Catalog Component Manufacturers • Low-Risk Components • Distributors of Catalog Components  • Consultants • Facility…

…13485 Certificates; Lead Auditor Certificate; Resume, etc., are acceptable in lieu of survey. • Standard Catalog Component Manufacturers • Low-Risk Components • Distributors of Catalog Components  • Consultants • Facility…

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Devine Guidance

CAPA is not Rocket Science

By Dr. Christopher Joseph Devine

…during an internal quality audit, returned product, and product complaints are a few examples of quality inputs requiring input into the CAPA system. The QSR specifically adds a callout for

…during an internal quality audit, returned product, and product complaints are a few examples of quality inputs requiring input into the CAPA system. The QSR specifically adds a callout for

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Devine Guidance

You Got a Warning Letter, Now What?

By Dr. Christopher Joseph Devine

…under the umbrella of an FDA warning letter, business as usual comes to an abrupt end. The agency is no longer obliged to review and approve new product submissions. Can…

…under the umbrella of an FDA warning letter, business as usual comes to an abrupt end. The agency is no longer obliged to review and approve new product submissions. Can…

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Ask the Engineer

Ask The Engineer: Sticky Questions on Adhesives

…provide a letter at the beginning of a project stating that these adhesives do not contain DEHP or BPA. Click here to learn more about solvent-free, RoHS-compliant medical device adhesives…

…provide a letter at the beginning of a project stating that these adhesives do not contain DEHP or BPA. Click here to learn more about solvent-free, RoHS-compliant medical device adhesives…

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Richard Sokolov, Director-Product Development, ide+
MEDdesign

Minimum Viable Product

By Kevin Smith, Richard Sokolov

…from customers or investors for your new development project. However, to me this is more of a mock up or a prototype, not an MVP, and obtaining this sort of…

…from customers or investors for your new development project. However, to me this is more of a mock up or a prototype, not an MVP, and obtaining this sort of…

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

MHLW MO 169 – Chapter 5 – Mutatis Mutandis

By Dr. Christopher Joseph Devine

…in-vitro diagnostic reagents. Retrieved June 1, 2012, from http://www.pmda.go.jp/english/service/pdf/ministerial/050909betsu3.pdf Quality management system inspection of medical devices and in-vitro diagnostics in Japan. (2012). PMDA Website. Retrieved November 30, 2012, from http://www.pmda.go.jp/english/service/pdf/qms.pdf….

…in-vitro diagnostic reagents. Retrieved June 1, 2012, from http://www.pmda.go.jp/english/service/pdf/ministerial/050909betsu3.pdf Quality management system inspection of medical devices and in-vitro diagnostics in Japan. (2012). PMDA Website. Retrieved November 30, 2012, from http://www.pmda.go.jp/english/service/pdf/qms.pdf….

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

MHLW MO 169 – Chapter 4 – Documents & Records

By Dr. Christopher Joseph Devine

…in-vitro diagnostic reagents. Retrieved June 1, 2012, from http://www.pmda.go.jp/english/service/pdf/ministerial/050909betsu3.pdf Quality management system inspection of medical devices and in-vitro diagnostics in Japan. (2012). PMDA Website. Retrieved November 30, 2012, from http://www.pmda.go.jp/english/service/pdf/qms.pdf….

…in-vitro diagnostic reagents. Retrieved June 1, 2012, from http://www.pmda.go.jp/english/service/pdf/ministerial/050909betsu3.pdf Quality management system inspection of medical devices and in-vitro diagnostics in Japan. (2012). PMDA Website. Retrieved November 30, 2012, from http://www.pmda.go.jp/english/service/pdf/qms.pdf….

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Devine Guidance

MHLW MO 169 – Chapter 4 – Training

By Dr. Christopher Joseph Devine

…in-vitro diagnostic reagents. Retrieved June 1, 2012, from http://www.pmda.go.jp/english/service/pdf/ministerial/050909betsu3.pdf Quality management system inspection of medical devices and in-vitro diagnostics in Japan.  (2012). PMDA Website. Retrieved November 30, 2012, from http://www.pmda.go.jp/english/service/pdf/qms.pdf. …

…in-vitro diagnostic reagents. Retrieved June 1, 2012, from http://www.pmda.go.jp/english/service/pdf/ministerial/050909betsu3.pdf Quality management system inspection of medical devices and in-vitro diagnostics in Japan.  (2012). PMDA Website. Retrieved November 30, 2012, from http://www.pmda.go.jp/english/service/pdf/qms.pdf. …

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Devine Guidance

MHLW MO 169 – Chapter 4 – Testing

By Dr. Christopher Joseph Devine

…in-vitro diagnostic reagents. Retrieved June 1, 2012, from http://www.pmda.go.jp/english/service/pdf/ministerial/050909betsu3.pdf Quality management system inspection of medical devices and in-vitro diagnostics in Japan.  (2012). PMDA Website. Retrieved November 30, 2012, from http://www.pmda.go.jp/english/service/pdf/qms.pdf

…in-vitro diagnostic reagents. Retrieved June 1, 2012, from http://www.pmda.go.jp/english/service/pdf/ministerial/050909betsu3.pdf Quality management system inspection of medical devices and in-vitro diagnostics in Japan.  (2012). PMDA Website. Retrieved November 30, 2012, from http://www.pmda.go.jp/english/service/pdf/qms.pdf

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Devine Guidance

MHLW MO 169 – Chapter 4 – Process Control

By Dr. Christopher Joseph Devine

…in-vitro diagnostic reagents. Retrieved June 1, 2012, from http://www.pmda.go.jp/english/service/pdf/ministerial/050909betsu3.pdf Quality management system inspection of medical devices and in-vitro diagnostics in Japan.  (2012). PMDA Website. Retrieved November 30, 2012, from http://www.pmda.go.jp/english/service/pdf/qms.pdf

…in-vitro diagnostic reagents. Retrieved June 1, 2012, from http://www.pmda.go.jp/english/service/pdf/ministerial/050909betsu3.pdf Quality management system inspection of medical devices and in-vitro diagnostics in Japan.  (2012). PMDA Website. Retrieved November 30, 2012, from http://www.pmda.go.jp/english/service/pdf/qms.pdf

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