SES/Force4 team applies a Risk Management approach to the product development process that can reduce cost, time-to-market, and liability risk.
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...
eCommerce: A Match for Sustainable Offerings eCommerce has done something monumental in changing consumer consumption patterns that have previously existed for many decades. Retail environments, such as general stores or specialized outlets, have enabled consumers to...
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...
Get ready for an exciting event at Stress Engineering where we will be hosting the Regulatory Grade CM&S Evidence Generation using ASME V&V 40 V&V40 Forum! Join us for a day filled with insightful discussions, networking opportunities, and collaboration with industry and regulatory experts.
