Medical Device Medical Device 274 Questions Ask question Search Order By: ActiveClear Filter 0 Votes 1 Ans Isn’t CAPA purely a quality assurance team concern? 1.67K viewsMedical Device 0 Votes 1 Ans Must the person responsible for the quality system be a QA manager with no other responsibilities? 1.58K viewsMedical Device 0 Votes 1 Ans How often must I do quality audits? 1.41K viewsMedical Device 0 Votes 1 Ans How many people am I required to assign to the CAPA system? 1.47K viewsMedical Device 0 Votes 1 Ans Who is Required to Submit a 510(k)? 1.60K viewsMedical Device 0 Votes 1 Ans When is a 510(k) is Required? 1.62K viewsMedical Device 0 Votes 1 Ans When a 510(k) is Not Required? 1.63K viewsMedical Device 0 Votes 1 Ans Why the FDA charges a fee for medical device product reviews? 1.47K viewsMedical Device 0 Votes 1 Ans When a PMA (Premarket Approval) is Required? 1.49K viewsMedical Device 0 Votes 1 Ans What protocol needs to be followed to get a medical device approved? 1.59K viewsMedical Device 0 Votes 1 Ans What are the steps to prepare and submit a Premarket Notification (510(k)) application? 1.66K viewsMedical Device 0 Votes 1 Ans How can I find out how FDA will classify my device? 1.62K viewsMedical Device 0 Votes 1 Ans What are the Objectives of High-Quality FMEAs? 1.55K viewsMedical Device 0 Votes 1 Ans What are the Quality Characteristics of Effective FMEAs? 1.46K viewsMedical Device 0 Votes 1 Ans What is Failure Mode and Effects Analysis (FMEA)? 1.50K viewsMedical Device 0 Votes 1 Ans Does FMEA = risk management per ISO 14971? 1.35K 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? 1.51K 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” ? 1.26K viewsMedical Device 0 Votes 1 Ans What is ISO 14971? 1.50K viewsMedical Device 0 Votes 1 Ans What does “risk management” mean? 1.64K viewsMedical Device « Previous 1 2 … 7 8 9 10 11 … 13 14 Next » Question and answer is powered by anspress.net
