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.
What are the questions you should ask yourself, your colleagues, your customers and your networks to be at the forefront of the Connected Health transformation?
What are the questions you should ask yourself, your colleagues, your customers and your networks to be at the forefront of the Connected Health transformation?
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.
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.
