Complaint, complaints, and more complaints, if you want to play in the medical-device industry sandbox, device manufacturers better get use to the concept. Complaint and complaint handling is a daily…
Complaint, complaints, and more complaints, if you want to play in the medical-device industry sandbox, device manufacturers better get use to the concept. Complaint and complaint handling is a daily…
…Langer’s four basic requirements for a combined clinically-useful and commercially-successful idea: “You want a platform technology. You want a powerful blocking patent so that you own the space. You want…
…Langer’s four basic requirements for a combined clinically-useful and commercially-successful idea: “You want a platform technology. You want a powerful blocking patent so that you own the space. You want…
…example: a. When requested, no DHR for the research, research-waterload or the waterload software Version (b)(4) tested and distributed to customers was provided. b. There is no record of device…
…example: a. When requested, no DHR for the research, research-waterload or the waterload software Version (b)(4) tested and distributed to customers was provided. b. There is no record of device…
…master records (DMRs), as required by 21 CFR 820.181. For example, when requested, no DMR for the EGGSAS software used in the three 3CPM Electrogastrogram versions: Research, Research Waterload, and…
…master records (DMRs), as required by 21 CFR 820.181. For example, when requested, no DMR for the EGGSAS software used in the three 3CPM Electrogastrogram versions: Research, Research Waterload, and…
…commercial distribution by the manufacturer, as required by 21 CFR 820.180(b). For example, your firm documents the final inspection of the Water Lily on a checklist, but discards the checklist…
…commercial distribution by the manufacturer, as required by 21 CFR 820.180(b). For example, your firm documents the final inspection of the Water Lily on a checklist, but discards the checklist…
…read the QSR. Device manufacturers please generate written procedures to support compliance to the QSR. Device manufactures please, please, and pretty please, understand that compliance to the QSR is not…
…read the QSR. Device manufacturers please generate written procedures to support compliance to the QSR. Device manufactures please, please, and pretty please, understand that compliance to the QSR is not…
…April, Dr. D was about to be the proud owner of a new 57” flat-screen television. The second my eyes focused on the condition of the shipping container, I knew…
…April, Dr. D was about to be the proud owner of a new 57” flat-screen television. The second my eyes focused on the condition of the shipping container, I knew…
…on a carton or pouch, a pouch label, or even something as benign as a flash label, e.g. “New and Improved.” To complicate matters further, outside of the United States,…
…on a carton or pouch, a pouch label, or even something as benign as a flash label, e.g. “New and Improved.” To complicate matters further, outside of the United States,…
…couple of steps. In fact, device manufacturers have the freedom to tailor their approach to CAPA, to fit their specific business model, providing compliance to all of the QSR requirements…
…couple of steps. In fact, device manufacturers have the freedom to tailor their approach to CAPA, to fit their specific business model, providing compliance to all of the QSR requirements…
…from FDA’s Website, violations of 820.90 are plentiful. One of the trends Dr. D has noted while performing research and collecting information for DG is that several companies have racked…
…from FDA’s Website, violations of 820.90 are plentiful. One of the trends Dr. D has noted while performing research and collecting information for DG is that several companies have racked…
