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What do you do when regulatory requirements exceed reasonable engineering controls? August 4, 2015. August 5, 2015. Of this series, we talked about why regulatory requirements for medical device testing might exceed reasonable engineering controls. In this part, we’ll share the fourth of five real-life case studies in which we at MED Institute faced this kind of discrepancy. Our fourth case study involves a test of stent durability: the ability of the stent to maintain its structural function in vivo.

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MED Institute Blog | medinst.wordpress.com Reviews

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What do you do when regulatory requirements exceed reasonable engineering controls? August 4, 2015. August 5, 2015. Of this series, we talked about why regulatory requirements for medical device testing might exceed reasonable engineering controls. In this part, we’ll share the fourth of five real-life case studies in which we at MED Institute faced this kind of discrepancy. Our fourth case study involves a test of stent durability: the ability of the stent to maintain its structural function in vivo.

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MED Institute Blog | medinst.wordpress.com Reviews

https://medinst.wordpress.com

What do you do when regulatory requirements exceed reasonable engineering controls? August 4, 2015. August 5, 2015. Of this series, we talked about why regulatory requirements for medical device testing might exceed reasonable engineering controls. In this part, we’ll share the fourth of five real-life case studies in which we at MED Institute faced this kind of discrepancy. Our fourth case study involves a test of stent durability: the ability of the stent to maintain its structural function in vivo.

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What do you do when regulatory requirements exceed reasonable engineering controls? – Part 1 – MED Institute Blog

https://medinst.wordpress.com/2015/02/16/what-do-you-do-when-regulatory-requirements-exceed-reasonable-engineering-controls-part-1/comment-page-1

What do you do when regulatory requirements exceed reasonable engineering controls? February 16, 2015. April 8, 2015. What do you do when regulatory requirements exceed reasonable engineering controls? This is the first part in a six-part series that will answer that question through real-life case studies from MED Institute, a company that performs nonclinical medical device testing. Accept the regulatory body’s requirements. Convince the regulatory body that your controls are adequate. Each of these ch...

2

What do you do when regulatory requirements exceed reasonable engineering controls? – Part 1 – MED Institute Blog

https://medinst.wordpress.com/2015/02/16/what-do-you-do-when-regulatory-requirements-exceed-reasonable-engineering-controls-part-1

What do you do when regulatory requirements exceed reasonable engineering controls? February 16, 2015. April 8, 2015. What do you do when regulatory requirements exceed reasonable engineering controls? This is the first part in a six-part series that will answer that question through real-life case studies from MED Institute, a company that performs nonclinical medical device testing. Accept the regulatory body’s requirements. Convince the regulatory body that your controls are adequate. Each of these ch...

3

What do you do when regulatory requirements exceed reasonable engineering controls? – Part 2 – MED Institute Blog

https://medinst.wordpress.com/2015/05/07/what-do-you-do-when-regulatory-requirements-exceed-reasonable-engineering-controls-part-2/comment-page-1

What do you do when regulatory requirements exceed reasonable engineering controls? May 7, 2015. May 7, 2015. How bad is the worst? What do you do when regulatory requirements exceed reasonable engineering controls? What do you do when regulatory requirements exceed reasonable engineering controls? One thought on “ What do you do when regulatory requirements exceed reasonable engineering controls? Pingback: What do you do when regulatory requirements exceed reasonable engineering controls? What do you do...

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August 2015 – MED Institute Blog

https://medinst.wordpress.com/2015/08

What do you do when regulatory requirements exceed reasonable engineering controls? August 4, 2015. August 5, 2015. Of this series, we talked about why regulatory requirements for medical device testing might exceed reasonable engineering controls. In this part, we’ll share the fourth of five real-life case studies in which we at MED Institute faced this kind of discrepancy. Our fourth case study involves a test of stent durability: the ability of the stent to maintain its structural function in vivo.

5

July 2015 – MED Institute Blog

https://medinst.wordpress.com/2015/07

What do you do when regulatory requirements exceed reasonable engineering controls? July 7, 2015. July 13, 2015. Of this series, we talked about why regulatory requirements for medical device testing might exceed reasonable engineering controls. In this part, we’ll share the third of five real-life case studies in which we at MED Institute faced these kinds of discrepancies. The regulatory requirement was that the potential required to induce corrosion had to be greater than 600 mV. We had three options ...

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MED Institute Blog

What do you do when regulatory requirements exceed reasonable engineering controls? August 4, 2015. August 5, 2015. Of this series, we talked about why regulatory requirements for medical device testing might exceed reasonable engineering controls. In this part, we’ll share the fourth of five real-life case studies in which we at MED Institute faced this kind of discrepancy. Our fourth case study involves a test of stent durability: the ability of the stent to maintain its structural function in vivo.

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