Medical Device Medical Device 274 Questions Ask question Search Order By: ActiveClear Filter 0 Votes 1 Ans How are medical devices classified? 1.53K viewsMedical Device 0 Votes 1 Ans How can I get FDA approval for a medical device? 1.59K viewsMedical Device 0 Votes 1 Ans What is a 510(k) submission? 1.42K viewsMedical Device 0 Votes 1 Ans How long does it take FDA to approve a 510(k) submission? 1.59K viewsMedical Device 0 Votes 1 Ans What is an SID number? 1.64K viewsMedical Device 0 Votes 1 Ans What is LACF? 1.46K viewsMedical Device 0 Votes 1 Ans What is a Class 1 medical device? 1.70K viewsMedical Device 0 Votes 1 Ans What is an Active Pharmaceutical Ingredient (API)? 1.55K viewsMedical Device 0 Votes 1 Ans What is a Class 2 medical device? 1.59K viewsMedical Device 0 Votes 1 Ans What is a Class 3 medical device? 1.55K viewsMedical Device 0 Votes 1 Ans I am a contract manufacturer of electronic assemblies used in medical devices. Some of them are finished (accessories, eg, leadwires); some a not. What is my best approach? What kind of risk-management documentation should I have? I am 13485 certified. 1.67K viewsMedical Device 0 Votes 1 Ans Should the user and patient be part of FMEA system? 1.48K viewsMedical Device 0 Votes 1 Ans How would we perform an Application or System FMEA on this? 1.60K viewsMedical Device 0 Votes 1 Ans Is an application and system FMEA the same thing? 1.63K viewsMedical Device 0 Votes 1 Ans What are the concerns with CAPA? 1.51K viewsMedical Device 0 Votes 1 Ans What are the ISO rules on CAPA? 1.67K viewsMedical Device 0 Votes 1 Ans Tips for better CAPA implementation? 1.64K viewsMedical Device 0 Votes 1 Ans Does the FDA require that I use software to support CAPA? 1.43K viewsMedical Device 0 Votes 1 Ans What statistical methods does the FDA mandate we use to identify quality issues? 1.58K viewsMedical Device 0 Votes 1 Ans Is it acceptable to use only after sale support data in my CAPA? 1.51K viewsMedical Device « Previous 1 2 … 6 7 8 9 10 … 13 14 Next » Question and answer is powered by anspress.net
