Medical Device Medical Device 274 Questions Ask question Search Order By: ActiveClear Filter 0 Votes 1 Ans What are the required actions for 510(k) submission? 994 viewsMedical Device 0 Votes 1 Ans Should device manufacturers notify the FDA at least 90 days in advance? 1.15K viewsMedical Device 0 Votes 1 Ans What are the requirements for ISO 13485:2003? 1.12K viewsMedical Device 0 Votes 1 Ans Is training required for an auditor for ISO 13485:2003 ? 1.23K viewsMedical Device 0 Votes 1 Ans What is Medical Device Data System (MDDS)? 1.14K viewsMedical Device 0 Votes 1 Ans What is Medical Device Reporting (MDR)? 1.23K viewsMedical Device 0 Votes 1 Ans What is Premarket Approval (PMA) application? 1.02K viewsMedical Device 0 Votes 1 Ans What are the requirements for Premarket Approval (PMA)? 993 viewsMedical Device 0 Votes 1 Ans What are Medical Device Recalls? 1.06K viewsMedical Device 0 Votes 1 Ans Who Recalls Medical Devices? 1.23K viewsMedical Device 0 Votes 1 Ans What all information must be provided when reporting a complaint on a Medical Device? 1.30K viewsMedical Device 0 Votes 1 Ans What are the actions to be taken when there is Medical Device Failure? 1.18K viewsMedical Device 0 Votes 1 Ans What are the minimal labeling requirements on the package of a Medical Device? 1.08K viewsMedical Device 0 Votes 1 Ans What are the International Labeling Standards for an Medical Device? 1.02K viewsMedical Device 0 Votes 1 Ans What is the ‘CE’ Mark on a Medical Device? 892 viewsMedical Device 0 Votes 1 Ans What are GMP Requirements for Medical Device Suppliers? 1.27K viewsMedical Device 0 Votes 1 Ans Why is an FDA Inspection done? 1.17K viewsMedical Device 0 Votes 1 Ans Is ISO 13485:2003 Certification required? 1.06K viewsMedical Device 0 Votes 1 Ans Should an Equipment Use Log be maintained for non-dedicated equipment? Should it include listing which piece of equipment was used for that particular product at that particular moment? 1.09K viewsMedical Device 0 Votes 1 Ans Have there been discussions with WHO regarding the pre-clearance process for IVDs and taking account the results of an MDSAP audit? Will medical devices assessed by the WHO be included in the program at a later stage? 980 viewsMedical Device « Previous 1 2 … 11 12 13 14 Next » Question and answer is powered by anspress.net
