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FDA Draft Guidance
Our multi-disciplinary team has extensive experience in medical device simulation and testing, including but not limited to...
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EU Medical Device Classification
Understanding the classification of your medical device before CE marking is a critical step as it affects...
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Clinical Evaluation Report (CER) Literature Searching
To maintain compliance with heightened requirements under the Medical Device Directive (i.e., recent Notified Body implementation of...
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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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CDRH Science Update: Research Programs Webpages in the Office of Science and Engineering Laboratories at CDRH
The Office of Science and Engineering Laboratories (OSEL)/Center for Devices and Radiological Health (CDRH) is pleased 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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