Medical Device Medical Device 274 Questions Ask question Search Order By: ActiveClear Filter 0 Votes 1 Ans What is ISO? 1.45K viewsMedical Device 0 Votes 1 Ans What are the benefits of ISO certification? 1.57K viewsMedical Device 0 Votes 1 Ans How does a company get ISO certification? 1.64K viewsMedical Device 0 Votes 1 Ans If class I in Europe device can it be used in US FDA study? What about outside labeling? 1.42K viewsMedical Device 0 Votes 1 Ans What are the latest The Latest Developments in Medical Devices? 1.49K viewsMedical Device 0 Votes 1 Ans Should Life Science Companies Comply with ISO 9001 or ISO 13485…or Both? 1.43K viewsMedical Device 0 Votes 1 Ans What are the revision of the ISO 9001 standard? 1.42K viewsMedical Device 0 Votes 1 Ans What is Direct Part Mark (DPM) and what products require this? 1.53K viewsMedical Device 0 Votes 1 Ans What happens with products already produced and distributed once the UDI rule is in place? Would there be a need to re-label the products? 1.27K viewsMedical Device 0 Votes 1 Ans When does Zimmer need to be compliant with UDI requirements and have evidence to support compliance during an FDA audit? 1.61K viewsMedical Device 0 Votes 1 Ans What are GS1, GUDID, GDSNR, GLN and GTIN? 1.56K viewsMedical Device 0 Votes 1 Ans Why GS1? 1.47K viewsMedical Device 0 Votes 1 Ans Why is the Food and Drug Administration (FDA) requiring the UDI initiative? 1.52K viewsMedical Device 0 Votes 1 Ans Should I deal directly with the manufacturer of a dangerous medical device? 1.61K viewsMedical Device 0 Votes 1 Ans The FDA approved my medical device. Doesn’t that mean the device is safe? 1.39K viewsMedical Device 0 Votes 1 Ans Do you have any tips/tricks for looking up device information on the FDA website? Sometimes the manufacturer is not the same as the company now marketing the device, sometimes the device name is not listed exactly the same way, etc. 1.43K viewsMedical Device 0 Votes 1 Ans How do you determine whether a device is just being used in a study (like an approved MRI device, a device that makes a dental mold, a CT scanner) vs. a study device? Is there a rule of thumb for this? 1.26K viewsMedical Device 0 Votes 1 Ans In the US, if a device is Class I, 510(k), or PMA, does the IRB still need to document in the minutes whether the device is SR or NSR? 1.55K viewsMedical Device 0 Votes 1 Ans If a physical modification to a HUD doesn’t change the indication for use, should it be seen as a new device? 1.39K viewsMedical Device 0 Votes 1 Ans Can you talk about what kinds of documentation the IRB should request when reviewing studies that include MR-PET scanners, MRI, etc? What about hybrid devices? What do we need to know? 1.51K viewsMedical Device « Previous 1 2 … 9 10 11 12 13 14 Next » Question and answer is powered by anspress.net
