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المحتوى المقدم من Medical Product Outsourcing. يتم تحميل جميع محتويات البودكاست بما في ذلك الحلقات والرسومات وأوصاف البودكاست وتقديمها مباشرة بواسطة Medical Product Outsourcing أو شريك منصة البودكاست الخاص بهم. إذا كنت تعتقد أن شخصًا ما يستخدم عملك المحمي بحقوق الطبع والنشر دون إذنك، فيمكنك اتباع العملية الموضحة هنا https://ar.player.fm/legal.
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Examining Institutional Review Boards

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Manage episode 404991998 series 2805302
المحتوى المقدم من Medical Product Outsourcing. يتم تحميل جميع محتويات البودكاست بما في ذلك الحلقات والرسومات وأوصاف البودكاست وتقديمها مباشرة بواسطة Medical Product Outsourcing أو شريك منصة البودكاست الخاص بهم. إذا كنت تعتقد أن شخصًا ما يستخدم عملك المحمي بحقوق الطبع والنشر دون إذنك، فيمكنك اتباع العملية الموضحة هنا https://ar.player.fm/legal.

In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we’re looking at IRBs, or institutional review boards. We’re taking a look at what these are, how they relate to medical device approvals, and why they are important. Specifically, the following questions are addressed:

  • Could you please explain what an IRB or institutional review board is?
  • If I’m a device maker and am looking to conduct a clinical trial for one of my devices, do I need IRB approval?
  • Are there situations in which I would not need an IRB approval prior to a clinical trial?
  • Do you have suggestions on selecting an IRB? What I would want to look for and perhaps what I’d want to avoid?
  • What information do I need to provide to the IRB for its review?
  • What kind of timeline should I expect with the IRB review process?
  • Do I have any recourse if the IRB review comes back not in my favor?
  • What are the takeaways?

Listen to this discussion and see if you’ve gained insight for your next interaction with an IRB. If you’d like to share thoughts, ask questions, or have a suggestion for a future topic for us to cover, please reach out to me at sfenske@rodmanmedia.com and we’ll see if we want to address your ideas/inquiries/suggestions in a future episode.

For more medtech news and information, visit www.mpomag.com.

  continue reading

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Examining Institutional Review Boards

Medtech Matters

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iconمشاركة
 
Manage episode 404991998 series 2805302
المحتوى المقدم من Medical Product Outsourcing. يتم تحميل جميع محتويات البودكاست بما في ذلك الحلقات والرسومات وأوصاف البودكاست وتقديمها مباشرة بواسطة Medical Product Outsourcing أو شريك منصة البودكاست الخاص بهم. إذا كنت تعتقد أن شخصًا ما يستخدم عملك المحمي بحقوق الطبع والنشر دون إذنك، فيمكنك اتباع العملية الموضحة هنا https://ar.player.fm/legal.

In this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we’re looking at IRBs, or institutional review boards. We’re taking a look at what these are, how they relate to medical device approvals, and why they are important. Specifically, the following questions are addressed:

  • Could you please explain what an IRB or institutional review board is?
  • If I’m a device maker and am looking to conduct a clinical trial for one of my devices, do I need IRB approval?
  • Are there situations in which I would not need an IRB approval prior to a clinical trial?
  • Do you have suggestions on selecting an IRB? What I would want to look for and perhaps what I’d want to avoid?
  • What information do I need to provide to the IRB for its review?
  • What kind of timeline should I expect with the IRB review process?
  • Do I have any recourse if the IRB review comes back not in my favor?
  • What are the takeaways?

Listen to this discussion and see if you’ve gained insight for your next interaction with an IRB. If you’d like to share thoughts, ask questions, or have a suggestion for a future topic for us to cover, please reach out to me at sfenske@rodmanmedia.com and we’ll see if we want to address your ideas/inquiries/suggestions in a future episode.

For more medtech news and information, visit www.mpomag.com.

  continue reading

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