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FDA Cranks Up Pressure for Modeling and Simulation

FDA Cranks Up Pressure for Modeling and Simulation

FDA Cranks up Pressure for Modeling and Simulation   In November 2023, the FDA released new guidance new guidance on assessing the credibility of computational modeling and simulation (CM&S) in medical device submissions.   This guidance underscores the...

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The Real Secret of eCommerce Success…Grace

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In 2005 Procter and Gamble coined the term “First Moment of Truth” to describe the first 3-5 seconds the consumer’s eyes meet a product on the store shelf, likely adjacent to a competitor, and they make the decision to purchase that product over the competitor’s...

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In Silico Design Verification Testing of Medical Devices

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Once computational modeling and simulation (CM&S) was officially sanctioned by the FDA, “regulatory grade analysis” has become a rapidly growing trend in medical device development. SES Force-4’s leveraging of computational modeling and simulation based approaches...

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