Advanced virtualization technology can help you adhere to safety standards in your devices. • IEC 61508 Safety Systems • Aspects of IEC61508 System Design • Advanced Concepts for Safety & Security Jeff Fortin, Director of Field Engineering, Wind River
Microfluidics is an enabling technology which allows the development of highly integrated diagnostic or medical devices. We will present several examples of ...
This presentation will explore how additive manufacturing systems such as 3D printers and 3D production systems are changing the future of product developmen...
This presentation aims to remove the "magic" from gas plasma surface modification. How plasma creates a chemically reactive environment at low temperature is...
This presentation addresses how quality improvements and cost reduction go hand-in-hand. It introduces technologies that replace paper-based storage of produ...
The "Engineered to be Green" presentation will provide valuable insight into and best practices for sustainable machine design and redesign for machine builders (OEMs) and end-users. Niels Ouwersloot, Area Manager/Sales Engineer, Beckhoff Automation
Electron Beam Engineering was founded in 1991 and provides electron beam and laser welding services to a vast array of customers including many medical and aerospace companies. EB welding machines have progressed through the years and now offer a wide variety of features that allow for manipulating the components during welding. In 2008 we launched our own line of electron beam welding equipment called the "Beamer" series. Our line offers many modern features for today's intricate component designs and can provide weld penetration in steels from 0.001" to 0.7" at 30 inches per minute. Speaker: Richard E. Trillwood, CEO, Electron Beam Engineering, Inc.
Temporary Medical Devices (TMD) span a continuum of applications--from simple bandages to complex wound therapy systems, drug delivery patches, and passive a...
Toxikon at MDM East 2013, Philadelphia, PA
Biocompatibility testing involves the safety evaluation of medical devices and materials according to the guidelines set forth by regulatory bodies around the world such as ISO 10993, EP, USP, MHLW etc. Biocompatibility is typically performed on the final version of devices, although cases exist where specific tests are designed for the analysis of raw materials. The determination of which guideline to follow depends upon to which countries the devices will be submitted to, as well as the nature of what is being tested (medical device vs. raw material).
There are a number of low temperature sterilization options for medical device, pharmaceutical and biotech products. Today, the most common methods are: ethylene oxide (EO), gamma and hydrogen peroxide. EO is the oldest method, first used in the 1940-50's. Hydrogen peroxide was introduced in the early 1990's. Each method has its' strengths and weaknesses. With the rise of bioresorbable implants, drug-device combination products and prefilled syringes, more options are needed. This presentation will include the current sterilization technologies, and a discussion of the newest option, nitrogen dioxide gas. An overview of the strengths and weaknesses of NO2 will be discussed with a focus on the scientific data. One to two case histories will be shared demonstrating application to marketed products. In addition, a financial analysis will be presented contrasting the costs of contract sterilization vs. bringing sterilization in house. The intent is for this presentation will stimulate discussion in and questions from the attendees.
- Necessity and basics of cleaning and disinfection validations on reusable devices
- Non-patient contacting devices need cleaning and disinfection validations
- Simulated use of devices prior to the cleaning and disinfection validations
There are currently a number of innovative activities in the world of radiation sterilization. This presentation will provide an overview of those activities which include irradiation of tissue/biologics/combination products, new VDmax sterilization doses, discussions on use of SALs other than 10^-6 and a new approach to evaluating the potential impact that changes to SAL might have on patient safety.
Explains the mandatory removal of pfoa from the presently specified ptfe coatings [like Teflon(r)] and the EPA'a position. Then, covers the range of new coat...
This presentation will cover the basics of Very Long Fiber (VLF) reinforced thermoplastics and the unique performance benefits these compounds bring to metal...
Although the demand for reliability and safety has always been at the forefront in medical device design, the challenges of minimally invasive and micro/nano...