FDA FDA 1501 Questions Ask question Search Order By: ActiveClear Filter 0 Votes 1 Ans How do we get management on board with starting this effort now? 1.27K viewsFDA 0 Votes 1 Ans How should a company communicate to its Notified Body about timing for transitioning and implementing to ISO 13485:2016 and the new regulation? Is it appropriate to communicate using a change notification? Is there a standard process? 1.66K viewsFDA 0 Votes 1 Ans Will all Notified Bodies be re-designated? Is there a risk they won’t be? 1.62K viewsFDA 0 Votes 1 Ans What is Medical Imaging? 1.42K viewsFDA 0 Votes 1 Ans Are Radiology and Medical Imaging same? 1.33K viewsFDA 0 Votes 1 Ans What are the currently used Medical Imaging techniques? 1.56K viewsFDA 0 Votes 1 Ans What is a Telemedicine? 1.63K viewsFDA 0 Votes 1 Ans What is an EHR? 1.39K viewsFDA 0 Votes 1 Ans We’ve already started down the road with our medical device. Is it too late to involve Sterling? 1.58K viewsFDA 0 Votes 1 Ans Our company does not yet have a quality system in place. How can we move forward? 1.46K viewsFDA 0 Votes 1 Ans How can Sterling bring my device to market faster? 1.63K viewsFDA 0 Votes 1 Ans I know we need a prototype but we haven’t got the seed funding yet. 1.48K viewsFDA 0 Votes 1 Ans Why not do the medical development for our device in house? 1.55K viewsFDA 0 Votes 1 Ans Why should we select Sterling over offshore alternatives? 1.28K viewsFDA 0 Votes 1 Ans Are all medical device development companies credentialed equally? 1.60K viewsFDA 0 Votes 1 Ans Which devices are exempt from regulatory review by FDA? 1.70K viewsFDA 0 Votes 1 Ans What is an IDE? 1.63K viewsFDA 0 Votes 1 Ans What is a PMA? 1.63K viewsFDA 0 Votes 1 Ans What is a Humanitarian Device Exemption (HDE)? 1.60K viewsFDA 0 Votes 1 Ans What are the regulations that manufacturer must comply in the United States? 1.59K viewsFDA « Previous 1 2 … 67 68 69 70 71 … 75 76 Next » Question and answer is powered by anspress.net
