Medical Device Medical Device 274 Questions Ask question Search Order By: ActiveClear Filter 0 Votes 1 Ans What is ISO? 1.66K viewsMedical Device 0 Votes 1 Ans What are the benefits of ISO certification? 1.75K viewsMedical Device 0 Votes 1 Ans How does a company get ISO certification? 1.82K viewsMedical Device 0 Votes 1 Ans If class I in Europe device can it be used in US FDA study? What about outside labeling? 1.63K viewsMedical Device 0 Votes 1 Ans What are the latest The Latest Developments in Medical Devices? 1.69K viewsMedical Device 0 Votes 1 Ans Should Life Science Companies Comply with ISO 9001 or ISO 13485…or Both? 1.65K viewsMedical Device 0 Votes 1 Ans What are the revision of the ISO 9001 standard? 1.59K viewsMedical Device 0 Votes 1 Ans What is Direct Part Mark (DPM) and what products require this? 1.80K 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? 1.51K 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? 1.95K viewsMedical Device 0 Votes 1 Ans What are GS1, GUDID, GDSNR, GLN and GTIN? 1.76K viewsMedical Device 0 Votes 1 Ans Why GS1? 1.83K viewsMedical Device 0 Votes 1 Ans Why is the Food and Drug Administration (FDA) requiring the UDI initiative? 1.86K viewsMedical Device 0 Votes 1 Ans Should I deal directly with the manufacturer of a dangerous medical device? 1.83K viewsMedical Device 0 Votes 1 Ans The FDA approved my medical device. Doesn’t that mean the device is safe? 1.61K 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. 1.64K 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? 1.46K 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? 1.72K 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? 1.62K 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? 1.71K viewsMedical Device « Previous 1 2 … 9 10 11 12 13 14 Next » Question and answer is powered by anspress.net
