Real Time Aging for Medical Devices

Life Sciences | Medical & Pharmaceutical | Medical Device | Tech Library

The SES/Force-4 approach to real time aging for medical products and devices.

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Custom Rubber-Seal Design

The Challenge: A silicone rubber seal design issue was perceived as poor workmanship, manifested as visible gaps in the part assemblies of a household consumer appliance, potentially harming the brand image. Directly competing design requirements were at play. A high...

FDA Cranks Up Pressure for Modeling and Simulation

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

In Silico Design Verification Testing of Medical Devices

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...