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What Should You Do When a Testing Standard Doesn’t Exist? Part 5: Forming an Industry Consortium
In part four of this series, we talked about employing a third party to build testing equipment...
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What Should You Do When a Testing Standard Doesn’t Exist? Part 4: Employ a third party to build testing equipment
In part three of this series, we talked about validating your own test method and gaining FDA...
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What Should You Do When a Testing Standard Doesn’t Exist? Part 3: Develop and Validate your own Test Method
In part two of this series, we talked about working together with the standard organizations to develop...
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What Should You Do When a Testing Standard Doesn’t Exist? Part 2: Working through Standards Organizations
In part one of this series, we discussed how medical device technology can frequently outpace the development...
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What Should You Do When a Testing Standard Doesn’t Exist? Part 1: Introduction
This is the first part in a six-part series that will help explain your options. When a...
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Medical Device MRI Safety Testing: Where should a hip implant be placed in an ASTM F2182 test to measure the maximum RF-induced heating?
As mentioned in our previous case study , testing the radio-frequency-induced tissue heating by implanted medical devices is...
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Medical Device MRI Safety Testing: Where should you measure temperature when testing RF-induced heating of a complicated structure?
Regarding MRI safety, testing the radio-frequency-induced heating of implanted medical devices is important to prevent harm to...
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Medical Device MRI Safety Testing: What do you do when device deflection under MR scanning exceeds the ASTM reference point?
For a device to be used in an MR environment, it needs to be evaluated for magnetic...
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What kinds of MR tests are performed when evaluating safety?
What kinds of MR tests are performed? Many virtual and physical tests are used to evaluate the...
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Why is it important to label devices for MR safety?
If a patient has an implanted medical device that contains metal, then an MR scan can...
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What do you do when regulatory requirements exceed reasonable engineering controls? – Part 3
In part two of this series, we talked about why regulatory requirements for medical device testing might...
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MED Institute doesn’t just meet standards—it sets them.
MED Institute not only adheres to medical-device testing standards but also helps to set them, working with...
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