Questions Ask question Search Order By: ActiveCategoryClear Filter 0 Votes 1 Ans Your license application form requests information concerning the types of devices I manufacture or distribute. What are Class I, II and III devices? 1.68K viewsMedical Device 0 Votes 1 Ans My company is a corporation and The Texas Business Organizations Code (“BOC”) license application form asks for a Registered Agent. Who is that? 1.58K viewsMedical Device 0 Votes 1 Ans What is a Taxpayer I.D. #? The Texas Business Organizations Code (“BOC”) 1.66K viewsMedical Device 0 Votes 1 Ans What must I do if I identify non-conforming product? 1.71K viewsMedical Device 0 Votes 1 Ans How can I prove that my corrective or preventive action resolved the issue? 1.56K viewsMedical Device 0 Votes 1 Ans How long must I store records? 1.57K viewsMedical Device 0 Votes 1 Ans What is a medical device listing number? 1.49K viewsMedical Device 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? 1.60K viewsMedical Device 0 Votes 1 Ans What is a 510(k) submission? 1.43K viewsMedical Device 0 Votes 1 Ans How long does it take FDA to approve a 510(k) submission? 1.60K viewsMedical Device 0 Votes 1 Ans What is an SID number? 1.64K viewsMedical Device 0 Votes 1 Ans What is LACF? 1.47K 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)? 1.56K viewsMedical Device 0 Votes 1 Ans What is a Class 2 medical device? 1.60K viewsMedical Device 0 Votes 1 Ans What is a Class 3 medical device? 1.56K 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. 1.68K viewsMedical Device 0 Votes 1 Ans Should the user and patient be part of FMEA system? 1.49K viewsMedical Device 0 Votes 1 Ans How would we perform an Application or System FMEA on this? 1.61K viewsMedical Device « Previous 1 2 … 190 191 192 193 194 … 283 284 Next » Question and answer is powered by anspress.net
