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

FDAā€™s Inspection Process

By Dr. Christopher Joseph Devine

…for complying with the FDA’s quality system regulation – 21 CFR, Part 820. Charleston, SC: Amazon. Investigations operations manual. (2013). Chapter 5 Establishment Inspections. Retrieved September 8, 2013, from http://www.fda.gov/downloads/ICECI/Inspections/IOM/UCM150576.pdf….

…for complying with the FDA’s quality system regulation – 21 CFR, Part 820. Charleston, SC: Amazon. Investigations operations manual. (2013). Chapter 5 Establishment Inspections. Retrieved September 8, 2013, from http://www.fda.gov/downloads/ICECI/Inspections/IOM/UCM150576.pdf….

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

Design History File

By Dr. Christopher Joseph Devine

…how the manufacturer of medical devices does not understand the concept of establishing a DHF. Considering the amount of work required in support of compiling a 510(k) or a PMA…

…how the manufacturer of medical devices does not understand the concept of establishing a DHF. Considering the amount of work required in support of compiling a 510(k) or a PMA…

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MEDdesign

Where Have All the Systems Engineers Gone? Part Two

By Christopher Miles

…then architecture. Today’s architect must take a holistic view of the stakeholder needs and actively ensure alignment of the architecture to those needs while providing a level of flexibility in…

…then architecture. Today’s architect must take a holistic view of the stakeholder needs and actively ensure alignment of the architecture to those needs while providing a level of flexibility in…

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

What Makes a Good Auditor?

By Dr. Christopher Joseph Devine

…you are aware that there is no formal requirement for auditors to be certified. If a registrar or notified body states that your auditors must be certified, PUSH BACK! If…

…you are aware that there is no formal requirement for auditors to be certified. If a registrar or notified body states that your auditors must be certified, PUSH BACK! If…

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

Can You Say Recall?

By Dr. Christopher Joseph Devine

…within Part 806. Make sure you focus on the customer notification process, the product recovery process, good-faith effort process, effectiveness checks, the reporting process to FDA, and the certified destruction…

…within Part 806. Make sure you focus on the customer notification process, the product recovery process, good-faith effort process, effectiveness checks, the reporting process to FDA, and the certified destruction…

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Devine Guidance

Class I Devices in the United States

By Dr. Christopher Joseph Devine

…information is submitted by using FDA’s Unified Registration and Listing System (FURLS)/ Device Registration and Listing Module (DRLM) at: http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/RegistrationandListing/ucm053185.htm9 IMPORTANT NOTE: Only the class I devices with an asterisk…

…information is submitted by using FDA’s Unified Registration and Listing System (FURLS)/ Device Registration and Listing Module (DRLM) at: http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/RegistrationandListing/ucm053185.htm9 IMPORTANT NOTE: Only the class I devices with an asterisk…

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Devine Guidance

Failure to Define

By Dr. Christopher Joseph Devine

…readers already know, Dr. D loves to pontificate about regulatory compliance and the need to have documented evidence to support claims of compliance. In fact, Dr. D’s rants on compliance…

…readers already know, Dr. D loves to pontificate about regulatory compliance and the need to have documented evidence to support claims of compliance. In fact, Dr. D’s rants on compliance…

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Devine Guidance

Product Seizure

By Dr. Christopher Joseph Devine

…truck. However, make no mistake seizure is one of the more powerful tools in the FDA’s compliance tool chest. They have ways of making you comply. Enjoy. FDA’s definition of…

…truck. However, make no mistake seizure is one of the more powerful tools in the FDA’s compliance tool chest. They have ways of making you comply. Enjoy. FDA’s definition of…

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Devine Guidance

Detention

By Dr. Christopher Joseph Devine

…masks can be categorized as a “fungible” (look-it-up) commodity; however, approval/clearance is still required to enter these devices into commerce in the United States. Just maybe, someone at Lucky might…

…masks can be categorized as a “fungible” (look-it-up) commodity; however, approval/clearance is still required to enter these devices into commerce in the United States. Just maybe, someone at Lucky might…

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Devine Guidance

Calibration

By Dr. Christopher Joseph Devine

…claims of compliance.” 21 CFR, Part 820.72 – Inspection, Measuring, and Test Equipment (a) Control of inspection, measuring, and test equipment. Each manufacturer shall ensure that all inspection, measuring, and…

…claims of compliance.” 21 CFR, Part 820.72 – Inspection, Measuring, and Test Equipment (a) Control of inspection, measuring, and test equipment. Each manufacturer shall ensure that all inspection, measuring, and…

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