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.
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.
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.
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.
You must have a Device Master Record, so just go ahead and create one; once the DMR has been assembled, do not forget to update it.
You must have a Device Master Record, so just go ahead and create one; once the DMR has been assembled, do not forget to update it.
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.
Good Document Practices continues to be problematic for device manufacturers and their suppliers.
Good Document Practices continues to be problematic for device manufacturers and their suppliers.
This week, the doctor provides you a brief parody on the little differences and nuances between FDA and your friendly notified bodies.
This week, the doctor provides you a brief parody on the little differences and nuances between FDA and your friendly notified bodies.
FDA feels so strongly about the importance and composition of the DHR, that the Quality System Regulation (21 CFR, Part 820) contains a section dedicated to this.
FDA feels so strongly about the importance and composition of the DHR, that the Quality System Regulation (21 CFR, Part 820) contains a section dedicated to this.
Please ensure that the cleanroom/controlled environment has been properly validated and that adequate ongoing monitoring of the operating environment be sustained.
Please ensure that the cleanroom/controlled environment has been properly validated and that adequate ongoing monitoring of the operating environment be sustained.
