Questions Ask question Search Order By: ActiveCategoryClear Filter 0 Votes 1 Ans What are the Quality Characteristics of Effective FMEAs? 1.47K viewsMedical Device 0 Votes 1 Ans What is Failure Mode and Effects Analysis (FMEA)? 1.51K viewsMedical Device 0 Votes 1 Ans Does FMEA = risk management per ISO 14971? 1.36K viewsMedical Device 0 Votes 1 Ans Can I apply ISO 14971 if I´m the supplier/distributor/performer of part of the process of medical device manufacturing? 1.52K viewsMedical Device 0 Votes 1 Ans I do not have the “full picture” of the device design (and lifecycle design). I am a contract manufacturer for an electronic medical device and it has no sterilization. Do I really perform a medical device risk management process by ISO 14971 ? Can it be said as “Not Applicable” ? 1.27K viewsMedical Device 0 Votes 1 Ans What is ISO 14971? 1.50K viewsMedical Device 0 Votes 1 Ans What does “risk management” mean? 1.65K viewsMedical Device 0 Votes 1 Ans Is there a connection between ISO 14971 and ISO 13485? 1.38K viewsMedical Device 0 Votes 1 Ans Why is MasterControl interested in ISO 14971? 1.58K viewsMedical Device 0 Votes 1 Ans Is my product a medical device? 1.53K viewsMedical Device 0 Votes 1 Ans What Medical Device requirements are verified at the time of importation? 1.39K viewsMedical Device 0 Votes 1 Ans How does FDA verify compliance with the Medical Device requirements? 1.28K viewsMedical Device 0 Votes 1 Ans How does FDA verify registration and listing? 1.43K viewsMedical Device 0 Votes 1 Ans How do I obtain the manufacturer’s registration and listing information? 1.60K viewsMedical Device 0 Votes 1 Ans Why do medical devices require premarket submissions? 1.57K viewsMedical Device 0 Votes 1 Ans How does FDA verify premarket submissions? 1.63K viewsMedical Device 0 Votes 1 Ans How do I obtain information on premarket submissions for specific products? 1.62K viewsMedical Device 0 Votes 1 Ans What is Substantial Equivalence? 1.68K viewsMedical Device 0 Votes 1 Ans What are the revision of the ISO 13485:2016 standard? 1.49K viewsMedical Device 0 Votes 1 Ans What are the Key Differences ISO 9001 or ISO 13485? 1.46K viewsMedical Device « Previous 1 2 … 192 193 194 195 196 … 283 284 Next » Question and answer is powered by anspress.net