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Created to elevate expertise in testing, verification, and validation with industry-specific terminology, readers are empowered to navigate the complex world of quality assurance. From foundational concepts to advanced principles, each entry provides clarity and depth, ensuring the reader becomes well-versed in the language of precision. This dictionary is an indispensable companion for both professionals and students seeking to unravel the nuances of testing methodologies, verification techniques, and validation processes. Readers will be equipped with the tools to communicate effectively, make informed decisions, and excel in projects. In addition, references to SAE Standards are included to direct the reader to additional information beyond a practical definition.

To improve the biofidelity of the currently available Hybrid III 10-year-old (HIII-10C) Anthropomorphic Test Device (ATD), the National Highway Traffic Safety Administration (NHTSA) has developed the Large Omnidirectional Child (LODC) ATD. The LODC head is a redesigned HIII-10C head with mass properties and modified skin material required to match pediatric biomechanical impact response targets from the literature. A dynamic, nonlinear finite element (FE) model of the LODC head has been developed using the mesh generating tool Hypermesh based on the three-dimensional CAD model. The material data, contact definitions, and initial conditions are defined in LS-PrePost and converted to LS-Dyna solver input format. The aluminum head skull is stiff relative to head flesh material and was thus modeled as a rigid material. For the actual LODC, the head flesh is form fit onto the skull and held in place through contact friction.

ISO 13485:2016 is an international standard that establishes the requirements for a quality management system specific to the medical devices industry. It specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements. ISO 13485 is designed to be used by organizations involved in the design, production, installation and servicing of medical devices and related services.

Finite Element Analysis (FEA) is a powerful and well recognized tool used in the analysis of heat transfer problems. However, FEA can only analyze solid bodies and, by necessity thermal analysis with FEA is limited to conductive heat transfer. The other two types of heat transfer: convection and radiation must by approximated by boundary conditions. Modeling all three mechanisms of heat transfer without arbitrary assumption requires a combined use of FEA and Computational Fluid Dynamics (CFD).

Finite Element Analysis (FEA) has been an indispensable tool for design simulation for several decades but this wide spread use has been limited to simple types of analyses. Relatively recently, more advanced analyses have given easy-to-use interfaces enabling design engineers to simulate problems formerly reserved for analysts. FEA Beyond Basics targets the FEA users who wish to explore those advanced analysis capabilities. It will demonstrate how to move past the ubiquitous linear structural analysis and solve structural nonlinear problems characterized by nonlinear material, large displacements, buckling or nonlinear connectors.

Fatigue is a structural failure mode that must be recognized and understood to develop products that meet life cycle durability requirements. In the age of lightweighting, fatigue strength is an important vehicle design requirement as engineers struggle to meet stringent weight constraints without adversely impacting durability. This technical concept course introduces the fatigue failure mode and analysis methods. It explains the physics of material fatigue, including damage accumulation that may progress to product failure over time, and it provides the needed foundation to develop effective fatigue prediction capabilities.

ISO 14001:2015 is an environmental management standard (EMS) developed by the International Organization for Standardization (ISO). It’s a generic standard that can be used for any organization that provides physical products or services. ISO 14001 is the most widely used EMS because it’s both business and management oriented. However, the requirements must be carefully interpreted to make sense within a particular organization. For example, the environmental impact of developing automotive products is not the same as producing food products or offering consulting services, yet this standard can be applied to any of these activities.

Abstract Soft actuators with pneumatic network have innovative potential applications in medical and rehabilitation areas. The performance of this kind of actuators is determined by the design of chambers and the properties of the active extensible layer and the passive inextensible layer. In this article, actuator with isosceles trapezoidal chambers is proposed. Orthogonal experiment design and finite element method are used to optimize the structure of actuators. Results indicate that adding constrain-limiting paper in the passive layer can significantly reduce the bending radius. Position of the paper in the passive layer also affects the bending radius. Actuators with trapezoidal chambers can have a smaller bending radius compared with that with rectangle chambers. The bending radius decreases as the ratio of short base to long base of trapezoid decreases. Increasing the number density of chambers can further reduce the bending radius.

This course is offered in China only and presented in Mandarin Chinese. The course materials are bilingual (English and Chinese). Currently in the industry, especially within China, product requirement development is more of an experience-based process rather than a scientific methodology. This course addresses this issue and provides a more process-driven method for better requirement development through the Quality Function Deployment (QFD) methodology.  Real industrial examples are used to demonstrate how to systematically convert the voice of the customer data to engineering specifications using QFD.

This self paced course reviews the important facets of ISO 9001:2015, the most widely accepted quality management standard.  The standard can be applied to any organization that, regardless of its type or size, needs to demonstrate its ability to consistently provide products and services that enhance customer satisfaction and provide assurance of conformity to customer and applicable statutory and regulatory requirements.  This four-hour ISO 9001:2015 is a high level review.

ISO 13485:2016 is an international standard that establishes the requirements for a quality management system specific to the medical devices industry. It specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements. ISO 13485 is designed to be used by organizations involved in the design, production, installation and servicing of medical devices and related services.

ISO 13485:2016 is an international standard that establishes the requirements for a quality management system specific to the medical devices industry. It specifies requirements for a quality management system, and how to demonstrate compliance to meet customer and applicable regulatory requirements. ISO 13485 is designed to be used by organizations involved in the design, production, installation, and servicing of medical devices and related services. It can also be used by internal and external parties, such as certification bodies, to help them with their auditing processes.  Estimated to take up to 15-hours to complete.

This self paced course reviews the important facets of ISO 9001:2015, the most widely accepted quality management standard.  The standard can be applied to any organization that, regardless of its type or size, needs to demonstrate its ability to consistently provide products and services that enhance customer satisfaction and provide assurance of conformity to customer and applicable statutory and regulatory requirements. 

This self paced course reviews the important facets of ISO 9001:2015, the most widely accepted quality management standard.  The standard can be applied to any organization that, regardless of its type or size, needs to demonstrate its ability to consistently provide products and services that enhance customer satisfaction and provide assurance of conformity to customer and applicable statutory and regulatory requirements. Estimated to take up to 15 hours to complete,  this self paced course provides training on the standard, and how to lead or conduct internal audits and supplier audits using ISO 19011:2015.  

This self paced course reviews the important facets of ISO 9001:2015, the most widely accepted quality management standard.  The standard can be applied to any organization that, regardless of its type or size, needs to demonstrate its ability to consistently provide products and services that enhance customer satisfaction and provide assurance of conformity to customer and applicable statutory and regulatory requirements.

ISO 13485:2016 is an international standard that establishes the requirements for a quality management system specific to the medical devices industry. It specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements. ISO 13485 is designed to be used by organizations involved in the design, production, installation and servicing of medical devices and related services.

Under body blast (UBB) loading to military transport vehicles is known to cause foot-ankle fractures to occupants due to energy transfer from the vehicle floor to the feet of the soldier. The soldier posture, the proximity of the event with respect to the soldier, the personal protective equipment (PPE) and age/sex of the soldier are some variables that can influence injury severity and injury patterns. Recently conducted experiments to simulate the loading environment to the human foot/ankle in UBB events (~5ms rise time) with variables such as posture, age and PPE were used for the current study. The objective of this study was to determine statistically if these variables affected the primary injury predictors, and develop injury risk curves. Fifty below-knee post mortem human surrogate (PMHS) legs were used for statistical analysis. Injuries to specimens involved isolated and multiple fractures of varying severity.