Medical Device Medical Device 274 Questions Ask question Search Order By: ActiveClear Filter 0 Votes 1 Ans What are the 3 types of risks? 1.50K viewsMedical Device 0 Votes 1 Ans Can severity be reduced in risk assessment? 1.57K viewsMedical Device 0 Votes 1 Ans How are medical devices classified in general? 1.70K viewsMedical Device 0 Votes 1 Ans What is labeling in medical device? 1.65K viewsMedical Device 0 Votes 1 Ans What constitutes a medical device? 1.81K viewsClinical ResearchMedical Device 0 Votes 1 Ans What is GMP medical device? 1.76K viewsMedical Device 0 Votes 1 Ans Differentiate between Deviation Management and CAPA. How CAPA is important to Deviation Management (general)? 1.59K viewsMedical Device 0 Votes 1 Ans How can we qualify old equipments without any documents,though the same are working fine? 1.64K viewsMedical Device 0 Votes 1 Ans How does the FDA classify medical devices? 1.73K viewsMedical Device 0 Votes 1 Ans What is premarket notification (510(k)) submission? 1.54K viewsMedical Device 0 Votes 1 Ans What is a premarket approval (PMA) application? 1.70K viewsMedical Device 0 Votes 1 Ans What is a humanitarian device exemption (HDE) application? 1.63K viewsMedical Device 0 Votes 1 Ans What are the responsibilities of the IRBs regarding HDEs? 1.63K viewsMedical Device 0 Votes 1 Ans Does FDA require IRB review and approval of off-label use of a legally marketed device? 1.28K viewsMedical Device 0 Votes 1 Ans Must an IRB review a study conducted after submission of a (510(k)) to FDA but prior to FDA’s decision on that submission? 1.68K viewsMedical Device 0 Votes 1 Ans Can a physician use an unapproved device in an Emergency Situation? 1.65K viewsMedical Device 0 Votes 1 Ans What if the situation is not an emergency? Can a patient with serious illness or condition have access to an investigational device outside a study? 1.55K 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? 1.80K viewsMedical Device 0 Votes 1 Ans What are some of the biggest changes in the new regulations that will impact device manufacturers? 1.57K viewsMedical Device 0 Votes 1 Ans What is Medical Device Single Audit Program? 1.73K viewsMedical Device « Previous 1 2 3 4 … 13 14 Next » Question and answer is powered by anspress.net
