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Dr. Christopher Joseph Devine, President, Devine Guidance International
December 4, 2017
Dr. Christopher Joseph Devine, President, Devine Guidance International
Devine Guidance

Tanning Beds are Medical Devices, Who Knew?

By Dr. Christopher Joseph Devine

Document control is a critical part of your QMS.

Continue reading →

Dr. Christopher Joseph Devine, President, Devine Guidance International
November 16, 2017
Dr. Christopher Joseph Devine, President, Devine Guidance International
Devine Guidance

The DMR: It’s the Recipe, People

By Dr. Christopher Joseph Devine

The DMR is nothing more than the recipe (a.k.a. secret sauce), while the DHR is documented evidence of compliance.

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Dr. Christopher Joseph Devine, President, Devine Guidance International
November 8, 2017
Dr. Christopher Joseph Devine, President, Devine Guidance International
Devine Guidance

Sixteen Form 483 Observations. Ouch!

By Dr. Christopher Joseph Devine

There really is not much rocket science involved when attempting to determine the odds of a device establishment being awarded a prized agency warning letter when the establishment is on the receiving end of sixteen Form 483 observations during an inspection.

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Dr. Christopher Joseph Devine, President, Devine Guidance International
November 1, 2017
Dr. Christopher Joseph Devine, President, Devine Guidance International
Devine Guidance

Trick or Treat

By Dr. Christopher Joseph Devine

The doctor struggles to understand how the observation extracted from the warning letter referenced in this week’s guidance managed to rise to the level of a Form 483 Observation.

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Dr. Christopher Joseph Devine, President, Devine Guidance International
October 25, 2017
Dr. Christopher Joseph Devine, President, Devine Guidance International
Devine Guidance

Dr. D Sees a Trend

By Dr. Christopher Joseph Devine

There really is no excuse for receiving a Form 483 observation for management review.

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Dr. Christopher Joseph Devine, President, Devine Guidance International
October 19, 2017
Dr. Christopher Joseph Devine, President, Devine Guidance International
Devine Guidance

Dr. D Hates Receiving Inspection, Say What?

By Dr. Christopher Joseph Devine

Simply stated, an inspection needs to add some value; otherwise, what’s the point?

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Dr. Christopher Joseph Devine, President, Devine Guidance International
October 12, 2017
Dr. Christopher Joseph Devine, President, Devine Guidance International
Devine Guidance

Is Your Cleanroom Clean? Prove it!

By Dr. Christopher Joseph Devine

If a device establishment is going to invest significant time and money into building a cleanroom or a controlled environment room, it makes zero sense not to perform proper monitoring of the environment.

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Dr. Christopher Joseph Devine, President, Devine Guidance International
September 27, 2017
Dr. Christopher Joseph Devine, President, Devine Guidance International
Devine Guidance

Is Your Establishment’s Website Problematic?

By Dr. Christopher Joseph Devine

Visiting your establishment’s website and reviewing it for compliance issues is not a task that Dr. D routinely sees being performed by quality and regulatory professionals.

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Dr. Christopher Joseph Devine, President, Devine Guidance International
September 13, 2017
Dr. Christopher Joseph Devine, President, Devine Guidance International
Devine Guidance

Failure to Conduct Audits is Going to End Badly!

By Dr. Christopher Joseph Devine

It is Dr. D’s humble opinion that the execution of an effective internal audit program falls into the basic blocking and tackling bucket.

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Dr. Christopher Joseph Devine, President, Devine Guidance International
September 1, 2017
Dr. Christopher Joseph Devine, President, Devine Guidance International
Devine Guidance

No MDR Procedure: There is No Time Like the Present!

By Dr. Christopher Joseph Devine

When it comes to compliance, the FDA does not grant special dispensation.

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Columns

November 9, 2018
Devine Guidance

Refused Entry into the United States!

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

When adulterated products are manufactured in a foreign establishment, don’t expect FDA to admit them into the country.

October 26, 2018
Devine Guidance

Failure to Protect Patient Data is a Crime

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

All employees who handle patient information must be appropriately trained to HIPAA.

October 3, 2018
Devine Guidance

Device History Records and Rework

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

The FDA wants to know that rework activities are not impacting product safety and efficacy issues or influencing long-term product reliability.

September 11, 2018
Devine Guidance

Big Butts, Take Three!

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

It is our responsibility to educate family and friends about the dangers associated with the practicing of backroom medicine.

August 30, 2018
Devine Guidance

No Management Review?

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

It is one of the most basic of quality requirements.

August 9, 2018
Devine Guidance

What, No Risk Analysis?

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

Procedures for design validation must address risk analysis where appropriate.

July 12, 2018
Devine Guidance

One and Done:
It Happens!

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

When it comes to adverse event reporting, the FDA does not grant exemptions.

June 14, 2018
Devine Guidance

Big Butt Injections, the Saga Continues

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

In pursuit of the almighty dollar, this case involves the smuggling of lamb fat.

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