Questions Ask question Search Order By: ActiveCategoryClear Filter 0 Votes 1 Ans Is an application and system FMEA the same thing? 1.64K 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? 1.68K 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? 1.44K viewsMedical Device 0 Votes 1 Ans What statistical methods does the FDA mandate we use to identify quality issues? 1.59K viewsMedical Device 0 Votes 1 Ans Is it acceptable to use only after sale support data in my CAPA? 1.51K viewsMedical Device 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? 1.59K viewsMedical Device 0 Votes 1 Ans How often must I do quality audits? 1.42K viewsMedical Device 0 Votes 1 Ans How many people am I required to assign to the CAPA system? 1.48K viewsMedical Device 0 Votes 1 Ans Who is Required to Submit a 510(k)? 1.61K 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? 1.48K viewsMedical Device 0 Votes 1 Ans When a PMA (Premarket Approval) is Required? 1.50K viewsMedical Device 0 Votes 1 Ans What protocol needs to be followed to get a medical device approved? 1.60K viewsMedical Device 0 Votes 1 Ans What are the steps to prepare and submit a Premarket Notification (510(k)) application? 1.67K viewsMedical Device 0 Votes 1 Ans How can I find out how FDA will classify my device? 1.63K viewsMedical Device 0 Votes 1 Ans What are the Objectives of High-Quality FMEAs? 1.55K viewsMedical Device « Previous 1 2 … 191 192 193 194 195 … 283 284 Next » Question and answer is powered by anspress.net
