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MD&M West 2014: What do you do when regulatory requirements exceed that of reasonable engineering controls?
We all have the same goal: a safe medical device. Occasionally, the regulatory and company requirements are...
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MD&M West 2015: MRI safety evaluation and labeling of passive implants: Meeting the need with virtual and physical test capabilities.
We have developed virtual and physical test capabilities for MR safety evaluation of passive devices. We can...
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MD&M West 2016: Design Verification Testing: What should you do when a testing standard doesn’t exist?
It is important to be active in Standards Development when you need to publish a new standardized...
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In Vivo and In Vitro Nitinol Corrosion Properties
Regulatory authorities often require in vitro testing on medical devices prior to approval. Current standardized corrosion testing...
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MR ISMRM Salt Lake City
MR safety of electrically conducive passive implants is directly related to heating of the tissue in close...
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How do we identify the worst-case device for RF heating during MRI?
There are several safety concerns for patients with metallic implants who require MRI, including magnetic interactions (i.e.,...
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