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? 1.51K viewsMedical Device 0 Votes 1 Ans What are the revision of the ISO 9001 standard? 1.47K viewsMedical Device 0 Votes 1 Ans What is Direct Part Mark (DPM) and what products require this? 1.64K 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? 1.36K 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? 1.72K viewsMedical Device 0 Votes 1 Ans What are GS1, GUDID, GDSNR, GLN and GTIN? 1.64K viewsMedical Device 0 Votes 1 Ans Why GS1? 1.58K viewsMedical Device 0 Votes 1 Ans Why is the Food and Drug Administration (FDA) requiring the UDI initiative? 1.64K viewsMedical Device 0 Votes 1 Ans Should I deal directly with the manufacturer of a dangerous medical device? 1.70K viewsMedical Device 0 Votes 1 Ans The FDA approved my medical device. Doesn’t that mean the device is safe? 1.48K 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. 1.53K 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? 1.35K 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? 1.61K 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? 1.48K 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? 1.59K 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”? 1.78K viewsMedical Device 0 Votes 1 Ans For a contract fabricator, is it a requirement to test the raw materials offered by customers? 1.14K 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? 1.09K 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? 1.08K viewsDrugsPharmaceutical 0 Votes 1 Ans How long in advance can the raw materials be weighed? 1.18K viewsDrugsPharmaceutical « Previous 1 2 … 194 195 196 197 198 … 283 284 Next » Question and answer is powered by anspress.net
