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This course is verified by Probitas Authentication as meeting the AS9104/3A requirements for continuing Professional Development. 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.

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) 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 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.

The FDA requires employees to be trained in the current good manufacturing practice 21CFR210-211 as they relate to the employee's  functions to help assure the safety and efficacy of drug products. 

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.