Medical Device

Medical Device 248 Questions

0 Votes 1 Ans

Should an Equipment Use Log be maintained for non-dedicated equipment? Should it include listing which piece of equipment was used for that particular product at that particular moment?

10 viewsadmin Changed status to publish February 17, 2021Medical Device

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What if the situation is not an emergency? Can a patient with serious illness or condition have access to an investigational device outside a study?

23 viewsadmin Changed status to publish February 17, 2021Medical Device

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Can a physician use an unapproved device in an Emergency Situation?

19 viewsadmin Changed status to publish February 17, 2021Medical Device

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Must an IRB review a study conducted after submission of a (510(k)) to FDA but prior to FDA’s decision on that submission?

20 viewsadmin Changed status to publish February 17, 2021Medical Device

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Does FDA require IRB review and approval of off-label use of a legally marketed device?

25 viewsadmin Changed status to publish February 17, 2021Medical Device

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What are the responsibilities of the IRBs regarding HDEs?

23 viewsadmin Changed status to publish February 17, 2021Medical Device

0 Votes 1 Ans

What is a humanitarian device exemption (HDE) application?

12 viewsadmin Changed status to publish February 17, 2021Medical Device

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What is a premarket approval (PMA) application?

9 viewsadmin Changed status to publish February 17, 2021Medical Device

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What is premarket notification (510(k)) submission?

3 viewsadmin Changed status to publish February 17, 2021Medical Device

0 Votes 1 Ans

How does the FDA classify medical devices?

14 viewsadmin Changed status to publish February 17, 2021Medical Device

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What do you think might be the biggest difference between the requirements of FDA’s device requirements and EU’s MDR?

11 viewsadmin Changed status to publish February 17, 2021Medical Device

0 Votes 1 Ans

What is the best way to determine what is expected of Auditing Organizations with regard to multiple jurisdictions?

7 viewsadmin Changed status to publish February 17, 2021Medical Device

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?

8 viewsadmin Changed status to publish February 17, 2021Medical Device

0 Votes 1 Ans

What is Medical Device Single Audit Program?

6 viewsadmin Changed status to publish February 17, 2021Medical Device

0 Votes 1 Ans

What are some of the biggest changes in the new regulations that will impact device manufacturers?

3 viewsadmin Changed status to publish February 17, 2021Medical 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?

1.01K viewsadmin Changed status to publish January 1, 2021Medical 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

1.07K viewsadmin Changed status to publish December 31, 2020Medical Device

0 Votes 1 Ans

How CAPA is important to Deviation Management (general)?

699 viewsadmin Changed status to publish December 31, 2020Medical Device

0 Votes 1 Ans

How can we qualify old equipments without any documents,though the same are working fine?

930 viewsadmin Changed status to publish December 31, 2020Medical 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?

1.10K viewsadmin Changed status to publish October 19, 2020Medical Device

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