Tag Archives: QSR

Top 10 Reasons for FDA Warning Letters to Medical Device Firms

By Chris Celeste
1 Comment

The “Warning Letter” is considered by FDA to be the first step in the enforcement process, and a firm’s response to it may be its last chance, prior to a legal or administrative action, to adequately address a situation that FDA has concluded constitutes a violation.

The “Warning Letter” is considered by FDA to be the first step in the enforcement process, and a firm’s response to it may be its last chance, prior to a legal or administrative action, to adequately address a situation that FDA has concluded constitutes a violation.

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

Statistical Techniques

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

This week’s Devine Guidance on 21 CFR, Part 820 – Subpart O (Statistical Techniques) is the proverbial “Final Act” in regards to the QSR. There is a plethora of data, standards, and websites that can provide useful information needed to create robust procedure(s) for establishing effective statistical control and sampling plans. Establishing robust statistical procedures will mitigate the potential receipt of a Form 483.

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

Quality System Record

By Dr. Christopher Joseph Devine
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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

Identification and Traceability

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

The identification and traceability (sections 820.60 and 820.65) for products and finished medical devices, throughout the entire manufacturing process, including raw materials employed during the manufacturing process, and the subsequent sale and distribution of medical devices, are critical elements of the Quality System Regulation (QSR).

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

Purchasing Controls

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

FDA is really taking medical device manufacturers to task in regards to purchasing controls and the overall management of their suppliers. According to Kimberly Trautman, FDA’s current Good Manufacturing Practices (cGMP) and Quality System Regulations (QSR) expert, suppliers providing non-conforming material are directly related to an increase in medical device recalls; which increases the need for effective quality processes to mitigate risk. As the medical device industry continues to grow in leaps and…

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

Document Controls

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

The control of documentation is one the fundamental cornerstones supporting the foundation needed for an effective quality system, whether compliance is to EN ISO 13485, EN ISO 9000, the Medical Device Directive, or in the case of this series of Devine Guidance articles, the Quality System Regulation (QSR).

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

Design Transfer, Design Changes and Design History File

By Dr. Christopher Joseph Devine
No Comments
Dr. Christopher Joseph Devine, President, Devine Guidance International

In this fourth and final foray into Subpart C – Design Controls, Dr. D will review the last three subsections; (h) design transfer, (i) design changes, and (j) the design history file (DHF), located within section 820.30. These final three elements of design control are just as important as the previous subsections dissected as part of Devine Guidance.

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Devine Guidance

Design Input, Output, and Review

By Dr. Christopher Joseph Devine
No Comments

I hope that the readers of DG are able to glean some useful information from Dr. D’s frequent flights of rodomontade (look it up) pertaining to the need for compliance with regulations. As I emphatically opined in the previous edition of DG, medical devices that are safe and effective are born from a robust design and development process. Although I cannot speak on behalf of the agency, it would be a subreption of the regulations if I did not continue to state the overall importance of design control fo…

I hope that the readers of DG are able to glean some useful information from Dr. D’s frequent flights of rodomontade (look it up) pertaining to the need for compliance with regulations. As I emphatically opined in the previous edition of DG, medical devices that are safe and effective are born from a robust design and development process. Although I cannot speak on behalf of the agency, it would be a subreption of the regulations if I did not continue to state the overall importance of design control fo…

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