…limited to: Failure to adequately develop, maintain and implement written MDR procedures, as required by 21 CFR 803.17. For example, after reviewing your firm’s MDR procedure titled “QP-21-01-AH, Global Adverse…
…limited to: Failure to adequately develop, maintain and implement written MDR procedures, as required by 21 CFR 803.17. For example, after reviewing your firm’s MDR procedure titled “QP-21-01-AH, Global Adverse…
…through. They are starting to look more at product quality and performing risk-based inspections based on the data than they have through MDR’s, complaints, and CAPA. Electronic audits are also…
…through. They are starting to look more at product quality and performing risk-based inspections based on the data than they have through MDR’s, complaints, and CAPA. Electronic audits are also…
…Moreover, regardless of whether a complaint will warrant a MDR, all complaints must be “INVESTIGATED” as in determining the root cause of the problem the resulted in a complaint. If…
…Moreover, regardless of whether a complaint will warrant a MDR, all complaints must be “INVESTIGATED” as in determining the root cause of the problem the resulted in a complaint. If…
…written MDR procedures, as required by 21 CFR 803.17. For example, after reviewing your firm’s MDR procedure titled: MDR Procedure titled U.S. Medical Device Reporting, SOP-300024 Rev: 06 and Flow…
…written MDR procedures, as required by 21 CFR 803.17. For example, after reviewing your firm’s MDR procedure titled: MDR Procedure titled U.S. Medical Device Reporting, SOP-300024 Rev: 06 and Flow…
…individual MDRs or batches of MDRs. Note: It is Dr. D’s opinion; depending on the size of the batched of MDRs, this option may quickly garner agency attention. Additionally, FDA…
…individual MDRs or batches of MDRs. Note: It is Dr. D’s opinion; depending on the size of the batched of MDRs, this option may quickly garner agency attention. Additionally, FDA…
…FDA using the MDR (paper or eMDR). The doctor also recommends a weekly visit to the FDA’s MAUDE database to see what the agency is citing as compliance issues with…
…FDA using the MDR (paper or eMDR). The doctor also recommends a weekly visit to the FDA’s MAUDE database to see what the agency is citing as compliance issues with…
…addresses§820.198;” however, do not stop there. The complaint procedure also needs to link to Medical Device Reports (MDR) and the need to file MDRs within five or 30-days. In fact,…
…addresses§820.198;” however, do not stop there. The complaint procedure also needs to link to Medical Device Reports (MDR) and the need to file MDRs within five or 30-days. In fact,…
…recognize the importance of the DHR, try managing your organization’s complaint management system, performing a complaint investigation, filing an MDR, or even attempting to manage a RECALL (Dr. D’s favorite…
…recognize the importance of the DHR, try managing your organization’s complaint management system, performing a complaint investigation, filing an MDR, or even attempting to manage a RECALL (Dr. D’s favorite…
…Reports (MDR’s – another valuable acronym) or even worse a product RECALL, Dr. D’s favorite six-letter word, then 5-working days is not an unreasonable request. The doctor’s best advice is…
…Reports (MDR’s – another valuable acronym) or even worse a product RECALL, Dr. D’s favorite six-letter word, then 5-working days is not an unreasonable request. The doctor’s best advice is…
…U.S.C. 360i, and 21 CFR 803 – Medical Device Reporting (MDR) regulation. For example, when requested procedures for MDR reportable events were not provided. You should take prompt action to…
…U.S.C. 360i, and 21 CFR 803 – Medical Device Reporting (MDR) regulation. For example, when requested procedures for MDR reportable events were not provided. You should take prompt action to…
