Tag Archives: medical devices

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

MDD – Definitions and Scope

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

The Medical Device Directive encompasses a far more complex array of documents than the Quality System Regulation. The major takeaways from this edition of DG are: (a) significant changes made to the definitions of the MDD (21 March 10) should be clearly understood; (b) PPE requires a stand-alone and unique ERC; (c) depending on the application, software is now in scope of the MDD; and (d) combination devices require compliance to requirements delineated in multiple Directives.

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

Consent Decree

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

Consent decrees are expensive. Remember, consent decree and the resulting actions are driven by the courts and all bets are off in regards to when normal business operations will return, if ever. If the process of paying the third-party consultants does not grab the attention of the controller, rest assured the fines levied by the courts should. One final thought, with no new product approvals from FDA on the horizon, your competitors will be thanking you as your customer base and market share quickly be…

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

Responding to a Warning Letter

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

So your organization has received a warning letter from FDA – now what? For starters, the agency has quickly upped the ante in regards to taking the next steps in ensuring your organization clearly understands that a continued state of non-compliance is not acceptable. Warning letters are life-changing events for device manufacturers; however, they are recoverable. Dr. D recommends getting legal counsel and industry experts involved when responding to a warning letter, reviewing subsequent correspondence…

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

Responding to a Form 483

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

There are two options in regards to Form 483s: in option One, an organization can be proactive, accept the Form 483, and treat is as an opportunity for pursuing continuous improvement, while driving compliance to the QSR. In option Two, an organization can ignore the Form 483, and in doing so, be prepared to deal with the proverbial opening of the can of “FDA worms” and the subsequent warning letter that will be issued.

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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

Servicing

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

Servicing is a functional requirement, mandated by the Quality System Regulation, and often overlooked by device manufacturers. Though 21 CFR, Part 820.200 is often associated with capital equipment, manufacturers of disposable medical devices still must consider the requirement. It really is a mission critical assignment to provide adequate servicing for equipment deployed in healthcare facilities, while ensuring all of the relevant servicing activities are recorded, tracked trended, analyzed, etc.

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

Complaints (Subsections d and e)

By Dr. Christopher Joseph Devine
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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
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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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