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.
Notified bodies are not created equal nor are their auditors; and also, do not be afraid to push back.
Notified bodies are not created equal nor are their auditors; and also, do not be afraid to push back.
Unfortunately, Mr. Murphy is alive and well in the medical device industry, and it is inevitable that device manufacturers will have to handle non-conforming product.
Unfortunately, Mr. Murphy is alive and well in the medical device industry, and it is inevitable that device manufacturers will have to handle non-conforming product.
Medical device manufacturers should have a tool for communicating supplier issues back to their suppliers; and it’s always better to have documentation.
Medical device manufacturers should have a tool for communicating supplier issues back to their suppliers; and it’s always better to have documentation.
If you have not registered with FDA as an establishment and your organization meets the requirements delineated within Part 807, then what is stopping you?
If you have not registered with FDA as an establishment and your organization meets the requirements delineated within Part 807, then what is stopping you?
Not all auditing firms or auditors are created equal; in fact, there is “The Good, The Bad, and The Ugly” when it comes to auditors.
Not all auditing firms or auditors are created equal; in fact, there is “The Good, The Bad, and The Ugly” when it comes to auditors.
