Questions Ask question Search Order By: ActiveCategoryClear Filter 0 Votes 1 Ans Should Life Science Companies Comply with ISO 9001 or ISO 13485…or Both? 1.68K viewsMedical Device 0 Votes 1 Ans What are the revision of the ISO 9001 standard? 1.63K viewsMedical Device 0 Votes 1 Ans What is Direct Part Mark (DPM) and what products require this? 1.85K 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? 1.55K 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? 2.13K viewsMedical Device 0 Votes 1 Ans What are GS1, GUDID, GDSNR, GLN and GTIN? 1.81K viewsMedical Device 0 Votes 1 Ans Why GS1? 1.91K viewsMedical Device 0 Votes 1 Ans Why is the Food and Drug Administration (FDA) requiring the UDI initiative? 2.03K viewsMedical Device 0 Votes 1 Ans Should I deal directly with the manufacturer of a dangerous medical device? 1.87K viewsMedical Device 0 Votes 1 Ans The FDA approved my medical device. Doesn’t that mean the device is safe? 1.65K 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. 1.69K 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? 1.50K 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? 1.76K 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? 1.66K 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? 1.75K viewsMedical Device 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”? 2.11K viewsMedical Device 0 Votes 1 Ans For a contract fabricator, is it a requirement to test the raw materials offered by customers? 1.23K viewsDrugsPharmaceutical 0 Votes 1 Ans If the customer asks a contract fabricator not to test a finished product, is it necessary for the contract fabricator to test the product? 1.18K viewsDrugsPharmaceutical 0 Votes 1 Ans Is a contract fabricator or packager responsible for qualification of utilities and systems and cleaning validation or is it the responsibility of the distributor? And what about the validation of the manufacturing/packaging process and test methods? 1.17K viewsDrugsPharmaceutical 0 Votes 1 Ans How long in advance can the raw materials be weighed? 1.27K viewsDrugsPharmaceutical « Previous 1 2 … 194 195 196 197 198 … 283 284 Next » Question and answer is powered by anspress.net
