Medical Device Medical Device 274 Questions Ask question Search Order By: ActiveClear Filter 0 Votes 1 Ans If you had some new, unapproved *type* of blood glucose monitor in consideration w/ some new *type* of insulin, would the former be a “companion device”? 1.25K viewsMedical Device 0 Votes 1 Ans Why GHX? 941 viewsMedical Device 0 Votes 1 Ans What are the 6 FDA-Recommended Considerations for Smart and Safe Medical Device Interactions? 981 viewsMedical Device 0 Votes 1 Ans What are the 3 Steps to Achieving Manufacturing Operational Excellence? 1.29K viewsMedical Device 0 Votes 1 Ans ISO 13485 Countdown: What are the 5 Critical Tasks to Focus on Now? 1.29K viewsMedical Device 0 Votes 1 Ans What are the 7 QMS Tools to Demonstrate Compliance with 21 CFR Part 820 for Medical Devices? 909 viewsMedical Device 0 Votes 1 Ans What Are the Changes in ISO 13485:2016? 1.28K viewsMedical Device 0 Votes 1 Ans What are the 3 Things You Need to Know About the MDSAP? 1.04K viewsMedical Device 0 Votes 1 Ans What are the 4 Best Practices for Leading Metrics more specifically, the Corrective and Preventive Action (CAPA) process? 892 viewsMedical Device 0 Votes 1 Ans Can you describe some of the specific requirements that device manufacturers need to start preparing for? 969 viewsMedical Device 0 Votes 1 Ans How does Unique Device Identification (UDI) fit into the new regulations? 1.18K viewsMedical Device 0 Votes 1 Ans How will timing of the new regulations affect when companies need to start transitioning to the new law? 1.20K viewsMedical Device 0 Votes 1 Ans How can companies prepare for the unannounced audits that the MDR will require notified bodies to conduct? 1.22K viewsMedical Device 0 Votes 1 Ans What do you think companies can expect during audits from a risk management perspective? 1.18K viewsMedical Device 0 Votes 1 Ans We know the big companies have a lot of money and resources to throw into the transition. How will MDR affect smaller companies? 1.04K viewsMedical Device 0 Votes 1 Ans From a practical perspective, what do those companies need to be doing? 852 viewsMedical Device 0 Votes 1 Ans How does Brexit play into the MDR changes? 1.12K viewsMedical Device 0 Votes 1 Ans Is 510(k) mandatory? 867 viewsMedical Device 0 Votes 1 Ans What is substantial equivalence as a way to show the new device is safe? 1.25K viewsMedical Device 0 Votes 1 Ans What are the Types of 510(k) Submission? 928 viewsMedical Device « Previous 1 2 … 10 11 12 13 14 Next » Question and answer is powered by anspress.net
