Devine Guidance

Design Input, Output, and Review

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

Personnel Training

By Dr. Christopher Joseph Devine
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The FDA’s requirements for personnel are delineated within Section 820.25. In fact, Section 820.25 appears to be one of the more innocuous requirements and in the opinion of Dr. D, one of the most important. Can you say training, training, and more training? Regardless, compliance to the requirement is mandated by the regulation. That said, Dr. D would probably suffer from some compunction if I failed to cover all aspects of the regulations as part of this current series. As always, my goal is to enligh…

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

Quality Audits

By Dr. Christopher Joseph Devine
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The Food and Drug Administration (FDA) will evaluate the effectiveness of your internal quality audits and review the corrective actions pursued as part of the overall quality audit system. If a nefarious approach to executing quality audits is pursued, the reward will be a Form 483. If the FDA feels the violation is egregious, a warning letter will be forthcoming. In monopoly speak, “do not pass go and do not collect your two hundred dollars.” Warning letter violations As you can see by the abundance o…

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

Management Responsibility

By Dr. Christopher Joseph Devine
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I begin this edition of Devine Guidance  (DG) by reinforcing the importance of DG Rule #1 – Compliance to regulations is not optional, compliance is mandatory and dictated by law. In my belief, management responsibility is what the doctor likes to call the “catch-all requirement.” What does that mean Dr. D? Simply put, if your organization fails to comply with any part of the QSR, rest assured, the reward will be in the form of a Form 483 for the specific transgression, by the agency. Additionally,…

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

Nonconforming Products

By Dr. Christopher Joseph Devine
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In a perfect world, there would never be a need to handle non-conformances from your supplier base. However, the world of medical device manufacturing is far from perfect (please do not tell the regulators). You may call it fate, destiny, or bad luck, but Dr. D. calls it problem suppliers. Rest assured some of your suppliers will eventually deliver nonconforming product and at some point in the not-so-distant future, I will address managing nonconforming products as a whole. Warning letter violation Vio…

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

Purchasing Controls

By Dr. Christopher Joseph Devine
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Over the past two months, Dr. D has focused on supplier management from a quality and regulatory perspective. However, the successful execution of a well-defined supplier-management system, and the overall organizational success within the medical device industry, is premised on a strong cross-functional approach to quality. It takes a collegium (may need to look it up) of dedicated professionals, in multi-functional roles, to ensure all aspects of the supplier management system function efficiently. In…

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

Supplier Maintenance Assessments

By Dr. Christopher Joseph Devine
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If a supplier scored well on their original selection assessment, or scores well on repeat maintenance assessments—say, a score of 90 percent or above for argumentative sake—and your organization is receiving 100 percent conforming product (yes, imagine a perfect world), what is the value of performing an annual or regularly scheduled maintenance assessment? Dr. D does not see any upside. Now I could write a philippic (yep, look up time again) that takes medical device organizations to task in regards t…

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

Supplier Metrics

By Dr. Christopher Joseph Devine
No Comments

To ensure supplier surprises are kept to a bare minimum, an organization cannot simply rely on thaumaturgy (go ahead and look it up). Supplier performance must be continuously gauged for effectiveness, and a feedback loop created to ensure suppliers are receiving accurate information in regards to their overall performance. Additionally, supplier performance metrics should be included into your management review process. Management must be informed of parlous issues that can result in the need for field…

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