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? 1.42K viewsMedical Device 0 Votes 1 Ans Should device manufacturers notify the FDA at least 90 days in advance? 1.58K viewsMedical Device 0 Votes 1 Ans What are the requirements for ISO 13485:2003? 1.54K viewsMedical Device 0 Votes 1 Ans Is training required for an auditor for ISO 13485:2003 ? 1.66K viewsMedical Device 0 Votes 1 Ans What is Medical Device Data System (MDDS)? 1.56K viewsMedical Device 0 Votes 1 Ans What is Medical Device Reporting (MDR)? 1.64K viewsMedical Device 0 Votes 1 Ans What is Premarket Approval (PMA) application? 1.45K viewsMedical Device 0 Votes 1 Ans What are the requirements for Premarket Approval (PMA)? 1.43K viewsMedical Device 0 Votes 1 Ans What are Medical Device Recalls? 1.47K viewsMedical Device 0 Votes 1 Ans Who Recalls Medical Devices? 1.65K viewsMedical Device 0 Votes 1 Ans What all information must be provided when reporting a complaint on a Medical Device? 1.74K viewsMedical Device 0 Votes 1 Ans What are the actions to be taken when there is Medical Device Failure? 1.60K viewsMedical Device 0 Votes 1 Ans What are the minimal labeling requirements on the package of a Medical Device? 1.51K viewsMedical Device 0 Votes 1 Ans What are the International Labeling Standards for an Medical Device? 1.45K viewsMedical Device 0 Votes 1 Ans What is the ‘CE’ Mark on a Medical Device? 1.33K viewsMedical Device 0 Votes 1 Ans What are GMP Requirements for Medical Device Suppliers? 1.69K viewsMedical Device 0 Votes 1 Ans Why is an FDA Inspection done? 1.62K viewsMedical Device 0 Votes 1 Ans Is ISO 13485:2003 Certification required? 1.47K 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? 1.52K 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? 1.43K viewsMedical Device « Previous 1 2 … 11 12 13 14 Next » Question and answer is powered by anspress.net