…fail to file MDRs. Such stellar performance will be rewarded by a friendly visit from the agency, with a Form 482 in hand (a.k.a., notice of inspection). Warning letter violations…
…fail to file MDRs. Such stellar performance will be rewarded by a friendly visit from the agency, with a Form 482 in hand (a.k.a., notice of inspection). Warning letter violations…
…must file an MDR. Dr. D recommends a complaint file be opened for each complaint received. Confucius says, “It is better to over report than under report MDRs.” In closing,…
…must file an MDR. Dr. D recommends a complaint file be opened for each complaint received. Confucius says, “It is better to over report than under report MDRs.” In closing,…
…Reporting (MDR) process. Receive enough of these forms (a.k.a., MDRs); the device manufacturer can expect a visit from the agency. Warning letter violations The first warning letter observation falls into…
…Reporting (MDR) process. Receive enough of these forms (a.k.a., MDRs); the device manufacturer can expect a visit from the agency. Warning letter violations The first warning letter observation falls into…
…oversight rarely appears as a specific observation in FDA warning letters, but is often implied by critiques of MDR reporting or of design controls, notably 820.30(g), requiring that design validation…
…oversight rarely appears as a specific observation in FDA warning letters, but is often implied by critiques of MDR reporting or of design controls, notably 820.30(g), requiring that design validation…
…training needs, and company employees who are responsible for medical device manufacturing and complaint, CAPA, and Medical Device Report (MDR) handling are not adequately trained to ensure those duties are…
…training needs, and company employees who are responsible for medical device manufacturing and complaint, CAPA, and Medical Device Report (MDR) handling are not adequately trained to ensure those duties are…
