…complaint files and complete complaint handling procedures, as required by 21 C.F.R. § 820.198(a). Specifically, your firm is not always documenting enough information from the complainant so that an evaluation…
…complaint files and complete complaint handling procedures, as required by 21 C.F.R. § 820.198(a). Specifically, your firm is not always documenting enough information from the complainant so that an evaluation…
Complaints, complaints, and more complaints, extracted from the opening sentence from the previous edition of Devine Guidance, is also an appropriate introduction for this edition DG and Dr. D’s continued…
Complaints, complaints, and more complaints, extracted from the opening sentence from the previous edition of Devine Guidance, is also an appropriate introduction for this edition DG and Dr. D’s continued…
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…
…completeness, accuracy, and retained as evidence of compliance to the QSR and the DMR. Just a quick note from Dr. D in regards to expectations; the doctor has never experienced…
…completeness, accuracy, and retained as evidence of compliance to the QSR and the DMR. Just a quick note from Dr. D in regards to expectations; the doctor has never experienced…
…compliance (just kidding of course). In reality, the inspection resulted in two specific observations against 820.181. Not only was there an issue with the overall approach to compiling and sustaining…
…compliance (just kidding of course). In reality, the inspection resulted in two specific observations against 820.181. Not only was there an issue with the overall approach to compiling and sustaining…
…to prevent damage to records come into play, the safety of individuals may come into question (especially if the dogs are in the garage). My recommendation is to define, by…
…to prevent damage to records come into play, the safety of individuals may come into question (especially if the dogs are in the garage). My recommendation is to define, by…
…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…
…its intended use. If the device does not work, the device manufacturer will receive a complaint. If it is determined that a damaged device has resulted in patient injury or…
…its intended use. If the device does not work, the device manufacturer will receive a complaint. If it is determined that a damaged device has resulted in patient injury or…
…manufacturers need to have their quality systems reviewed, certified, and approved, by a recognized regulatory body, to circumvent their inerrable (look-it up) policies preventing compliance to the QSR. Now granted,…
…manufacturers need to have their quality systems reviewed, certified, and approved, by a recognized regulatory body, to circumvent their inerrable (look-it up) policies preventing compliance to the QSR. Now granted,…
…to keep in mind the potential impact to product safety and efficacy, regulatory compliance, and overall quality system effectiveness, resulting from CAPA driven changes to product, processes, and procedures. Warning…
…to keep in mind the potential impact to product safety and efficacy, regulatory compliance, and overall quality system effectiveness, resulting from CAPA driven changes to product, processes, and procedures. Warning…
