Medical Device Medical Device 274 Questions Ask question Search Order By: ActiveClear Filter 0 Votes 1 Ans Have there been discussions with WHO regarding the pre-clearance process for IVDs and taking account the results of an MDSAP audit? Will medical devices assessed by the WHO be included in the program at a later stage? 1.61K viewsMedical Device 0 Votes 1 Ans What is the best way to determine what is expected of Auditing Organizations with regard to multiple jurisdictions? 1.31K viewsMedical Device 0 Votes 1 Ans What do you think might be the biggest difference between the requirements of FDA’s device requirements and EU’s MDR? 1.56K viewsMedical Device 0 Votes 1 Ans What do you think might be the biggest difference between the requirements of FDA’s device requirements and the EU’s MDR? 1.70K viewsMedical Device 0 Votes 1 Ans How CAPA is important to Deviation Management (general)? 1.47K viewsMedical Device 0 Votes 1 Ans Where can really good indepth training materials be acquired for use in US and Asian organizations with respect to Quality Management Systems and compliance, including but not limited to document controls and CAPA – medical device design and manufacturing 1.67K viewsMedical Device 0 Votes 1 Ans How can we qualify old equipments without any documents,though the same are working fine? 1.62K viewsMedical Device 0 Votes 1 Ans Do generic drugs cause more side effects than brand name prescriptions? 1.61K viewsMedical Device 0 Votes 1 Ans What is a class action lawsuit? 1.46K viewsMedical Device 0 Votes 1 Ans When the FDA approves a drug can that drug be considered safe? 1.50K viewsMedical Device 0 Votes 1 Ans What is a single-use medical device? 1.54K viewsMedical Device 0 Votes 1 Ans To which single-use medical devices does this policy apply? 1.48K viewsMedical Device 0 Votes 1 Ans Can you give example(s) of when an IRB would not allow a sponsor to charge for a device? 1.59K viewsMedical Device 0 Votes 1 Ans How does an IRB decide who can present the risks/benefits of a complex device study (eg., physician or study coordinator)? What if the SC is not a medical professional? 1.60K viewsMedical Device 0 Votes 1 Ans Are there specific guidelines related to consenting children or adolescents? What is the age definition of child and adolescent? 1.61K viewsMedical Device 0 Votes 1 Ans When a commercial device is used in research in the population for which the device is intended, but the researcher plans to use a slightly different surgical procedure for putting the device in place does it require an IDE? 1.51K viewsMedical Device 0 Votes 1 Ans If an investigator develops a home-grown device that will be inserted into the heart chamber during open-heart surgery to measure internal pressures, but there is no intent to diagnose, treat, cure mitigate a disease or affect the structure/function of the body (it will be used to assess different physiologic conditions to understand the pathologenesis of disease), is the research FDA-regulated? In other words, they want to develop a device for future research on heart conditions, but it does not meet the definition of a medical device. Does the IRB need to insist that this device is classified by the FDA? Or can the IRB approve the study, noting that the device is not a medical device. 1.63K viewsMedical Device 0 Votes 1 Ans If a change to the UDI Device Identifier (UDI-DI) requires an update to the EC certificate, how long will this take? 1.62K viewsMedical Device 0 Votes 1 Ans What is the MDSAP? 1.51K viewsMedical Device 0 Votes 1 Ans What is the MDSAP Pilot Program? 1.51K viewsMedical Device « Previous 1 2 3 4 5 … 13 14 Next » Question and answer is powered by anspress.net
