Tag Archives: Chris Devine

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

Complaints (Subsections d and e)

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

Complaints, complaints, and more complaints, extracted from the opening sentence from the previous edition of Devine Guidance, is also an appropriate introduction for this edition DG and Dr. D’s continued diatribe on complaint management covering Subsections ‘d’ and ‘e.’ There is really only one takeaway from this edition of DG, complaints “shall be promptly reviewed, evaluated, and investigated.

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

Complaints (Subsections a, b, & c)

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

Whether major or minor, complaints require a significant organizational commitment to ensure a fastidious and consistent approach to complaint management. This week’s Devine Guidance will begin analyzing and providing insight and guidance needed for maintaining an effective compliant management system–mainly complying with 820.198, subsections a, b, and c.

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

Quality System Record

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

In this edition of Devine Guidance (DG), Dr. D will provide guidance for 21 CFR, Part 820, Subpart – M (Records), specifically 820.186 (Quality System Record). The Quality System Record, not to be confused with the Quality System Regulation, can be a document/procedure that points to where all documentation, procedures, and other records, required by the regulation are located, within the context of a device manufacturer’s quality system. The key for compiling a QSR and ongoing compliance with the QSR (y…

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

Device History Record

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

In this edition of Devine Guidance (DG), Dr. D will provide guidance for 21 CFR, Part 820, Subpart – M (Records), specifically 820.184 (Device History Record). The Device History Record (DHR) is a collection of activities such as production routers, as-built configurations, test and inspection results, copies of labeling, etc., retained for a specific device or batch of devices. Device manufacturers can take it to the proverbial bank: DHRs will be scrutinized during a routine inspection.

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

Device Master Record

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

In this edition of Devine Guidance , Dr. D will provide guidance for 21 CFR, Part 820, Subpart – M (Records), specifically 820.181 (Device Master Record). Ensuring the DMR is the receptacle for the appropriate type of records and the ongoing sustaining of the DMR are the basic salient requirements associated with 820.181. Remember, the DMR will never remain in a steady state.

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

Records (General Requirements)

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

In this edition of Devine Guidance (DG), Dr. D will provide guidance for 21 CFR, Part 820, Subpart – M (Records), specifically 820.180 (General Requirements). General requirements are boring; however, just like basic blocking and tackling drills in football, device manufacturers must get the basics correct.

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

Distribution and Installation

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

Distribution and installation are extremely important processes that ensure approved, safe, and effective medical devices make it into the hands of healthcare practitioners. In this edition of Devine Guidance (DG), Dr. D continues with his guidance for 21 CFR, Part 820, Subpart – L (Handling, Storage, Distribution, and Installation), specifically 820.160 (Distribution) and 820.170 (Installation).

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

Handling and Storage

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

Have you ever had the misfortune of ordering an item over the Internet, having it shipped to your home, and upon opening the box, finding the item badly damaged? Let’s face it ladies and gentlemen, regardless of the carrier, USPS, UPS, or Fedex, products take a beating during the rigors of “routine shipping and handling.” In this edition of Devine Guidance (DG), Dr. D will provide guidance for 21 CFR, Part 820, Subpart – L (Handling, Storage, Distribution, and Installation), specifically (820.140 –…

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

Labeling and Packaging Control

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

Labeling and what constitutes being a label can be confusing for device manufacturers. This week, Devine Guidance explains 21 CFR, Part 820 – Subpart – K, Labeling and Packaging Control, specifically 820.120 (Device Labeling) and 820.130 (Device Packaging). There are three takeaways: The accuracy of device labeling is mission-critical for device manufacturers; product packaging and labeling need to be properly validated, including distribution cycles, storage conditions, and useable shelf life; and famil…

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

Corrective and Preventive Action

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

In this edition of Devine Guidance , Dr. D provides guidance for 21 CFR, Part 820 – Subpart – J, Corrective and Preventive Action (CAPA), specifically (820.100). A strong CAPA system will allow organizations to track quality problems to closure. CAPA is not rocket science: you identify problems and you fix problems.

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