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Training / Education

Aviation Parts to Medical Devices Bridging the Gap

This one-day program is designed to provide introductory information for those organizations who are considering transitioning from the Aeronautic, Space and Defense industry to the Food & Drug Administration (FDA), Medical Device Manufacturing market. Reviewing essential information necessary to understand and successfully begin the journey to FDA Medical Device approval, this course will examine many of the controls between the AS9100 Standard and FDA Regulations and identify the similarities.
Technical Paper

Development and Calibration of the Large Omnidirectional Child ATD Head Finite Element Model

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.

Breath-Based Alcohol Detection System

This standard establishes the performance specifications for the zero-tolerance breath alcohol detection system to reduce the risks of driving under the influence of alcohol. It defines the accuracy and precision requirements of the BrAC measurement, as well as the acceptability criteria and key parameters to test these requirements. Additionally, this standard sets the performance requirements of the system for ethanol sensitivity, the response time, and the electrical, mechanical, and environmental conditions the system may encounter throughout the lifespan of the vehicle.
Training / Education

ISO 13485:2016 Overview

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.

Tech Briefs: April 2018

Laser Detecting Systems Enhancing Survivability and Lethality on the Battlefield Designing With Plastics for Military Equipment Engine Air-Brakes Paving the Way to Quieter Aircraft Nett Warrior Enhancing Battlefield Connectivity and Communications XPONENTIAL 2018 - An AUVSI Experience Communications in Space: A Deep Subject First Air-Worthy Metal-Printed RF Filter Ready for Takeoff Validation of Automated Prediction of Blood Product Needs Algorithm Processing Continuous Non-Invasive Vital Signs Streams (ONPOINT4) Using a combination of non-invasive sensors, advanced algorithms, and instruments built for combat medics could reduce hemorrhaging and improve survival rates. Calculation of Weapon Platform Attitude and Cant Using Available Sensor Feedback Successful development of mobile weapon systems must incorporate operation on sloped terrain.
Technical Paper

Human Foot-Ankle Injuries and Associated Risk Curves from Under Body Blast Loading Conditions

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.
Technical Paper

Communication - Hijacking - Occupational Safety What is the Connection?

People at work are frequently distracted (“hijacked”) by a mix of in and out of workplace events, frequently including poor communications. As a result, they sometimes find themselves in situations in which they can be seriously injured or killed. An investigation into the “how” these situations were initiated led to list of six primary causes. Based on this list, an experiential program was developed to help people remain focused on their work, not get hijacked, and improve their communications.