Tag Archives: medical devices

Devine Guidance

Product Seizure

By Dr. Christopher Joseph Devine
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The seizure process is just a tiny bit more complex than having U.S. Marshalls kicking in the doors and backing up and loading the proverbial turn-up truck. However, seizure is one of the more powerful tools in FDA’s compliance tool chest.

The seizure process is just a tiny bit more complex than having U.S. Marshalls kicking in the doors and backing up and loading the proverbial turn-up truck. However, seizure is one of the more powerful tools in FDA’s compliance tool chest.

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Devine Guidance

Detention

By Dr. Christopher Joseph Devine
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The concept of detention, employed by FDA, is not unlike the pain associated with the after school detention of this doctor’s wayward youth.

The concept of detention, employed by FDA, is not unlike the pain associated with the after school detention of this doctor’s wayward youth.

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Devine Guidance

Calibration

By Dr. Christopher Joseph Devine
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This is the 21 st  Century and if a device manufacturer has not figured out that gauges need to be calibrated and traceable to a national standard, e.g. NIST, then the device manufacturer is probably in the wrong business. 

This is the 21 st  Century and if a device manufacturer has not figured out that gauges need to be calibrated and traceable to a national standard, e.g. NIST, then the device manufacturer is probably in the wrong business. 

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Devine Guidance

Device History Record

By Dr. Christopher Joseph Devine
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When your friends from the agency stop by for that friendly cup of coffee and an inspection, they will ask to see DMRs and, eventually, review DHRs to verify finished medical devices are being properly manufactured.

When your friends from the agency stop by for that friendly cup of coffee and an inspection, they will ask to see DMRs and, eventually, review DHRs to verify finished medical devices are being properly manufactured.

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Devine Guidance

Identification & Traceability

By Dr. Christopher Joseph Devine
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Instead of attempting to rationalize why your current approach to identification and traceability is acceptable, just bite the bullet and script a high-level SOP.

Instead of attempting to rationalize why your current approach to identification and traceability is acceptable, just bite the bullet and script a high-level SOP.

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Devine Guidance

Receiving Inspection

By Dr. Christopher Joseph Devine
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If your organization decides to pursue and RI program, jump into the deep end of the pool with both feet and do not be afraid of getting wet.

If your organization decides to pursue and RI program, jump into the deep end of the pool with both feet and do not be afraid of getting wet.

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