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Packaging Test Methods for Validation of Sterile Barrier Materials
The purpose of this webinar will be to provide quality assurance, design engineers, project engineers and all medical device manufacturers the knowledge to make decisions regarding which tests should be used to validate their sterile barrier system. By focusing on specific tests as outline in ISO11607, each individual will have the opportunity to view actual test methods, determine appropriate test samples and identify pros and cons to each method. Some of the methods viewed will consist of Bubble Emission (ASTM F2096), Microbial Ranking (ASTM F1608), Burst Testing (ASTM F1140), Seal Strength Testing (ASTM F88), and Dye Migration (ASTM F1929).
Wed, Jul 20, 2011 - 01:47 pm
60 Minutes
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Managing Life Cycle Requirements for Developing and Maintaining Medical Device
Complying with the IEC 62304 standard to produce safe and effective medical devices requires that software design and development follows defined and controlled processes. This demands hardware and software teams to establish a common set of systems requirements, develop software with proper verifications, risk management, and maintain traceability. This is the third in the series on IEC62304 webinars that will take a deeper dive into managing requirements, modeling, testing, verification, and maintaining traceability throughout the product life cycle. It will demonstrate the power of team collaboration, and efficiency of re-usability to produce high quality reliable products, with lower costs and faster cycle times, that are safe, effective and compliant with regulations. Register now, it's FREE.
Thu, Jun 23, 2011 - 01:00 pm
60 Minutes
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Outsourcing Thermoplastics Extrusion? Lessons That Could Save You Thousands
Did you ever think you could save thousands of dollars by adjusting your tolerance by a half-thousandth of an inch (0.0005")? Did you realize you could do it without sacrificing any aspect of your product's performance? We'll tell you how one medical innovator did it through close collaboration with a contract manufacturer. You'll also learn the tricks to reducing time, frustration and failures so every medical device you design performs as you intend—from the design phase to full-scale manufacturing to the final point of care. You won't want to miss these lessons, as presented through dozens of recent case studies and real-life stories collected over decades. Join us for this revealing webinar on June 22 2011, at 12:00 PM ET. Register now, it's FREE.
Wed, Jun 22, 2011 - 12:00 pm
60 Minutes
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MEMS Inertial Sensors in Healthcare
MEMS inertial sensors are proving to be extremely versatile with usage only limited by the imagination of designers. Learn how this innovative technology is shaping next generation healthcare device designs. See why it is a viable alternative to optical or mechanical sensors that often have limitations on performance, size, power or cost. Understand how this innovative technology is being used for precise positioning in imaging systems, highly accurate guidance in surgical instruments, and accurate motion sensing in patient monitoring devices.You will learn the basics on MEMS motion sensing including:*Architectures and technology including accelerometers, gyroscopes, and inertial measurement units (IMUs) *Device specifications and understanding the critical parameters necessary depending on the specific application requirementsApplications explored include precise positioning/tracking of healthcare scanning equipment, surgical tool guidance, balance and control of prosthetics, and motion sensing in eldercare activity monitors and wellness devices. View now, it's FREE.Available on demand
Tue, Jun 7, 2011 - 03:17 pm
30 minutes
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Developments in Materials for Medical Applications
Join the content teams of European Medical Device Technology (EMDT), Medical Device and Diagnostic Industry (MD+DI), and Qmed for a virtual conference and trade show devoted to developments in materials for medical applications. The combined virtual conference and trade show offers the opportunity to learn from and interact directly with industry experts, thought-leaders, and technology providers direct from your desktop - virtually from anywhere you have online access.
Tue, May 24, 2011 - 06:00 am
8 hours
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The Big Three: Cytotoxicity, Sensitization & Irritation
There’s a myriad of tests medical device manufacturers need to be prepared to conduct on their creations in order to pass regulation requirements before they are released to the marketplace. None more important than the Cytotoxicity, Sensitization, and Irritation tests—the Big Three as we call them. They are the Big Three because they must be conducted on every device before they can be submitted to the Federal Drug Administration (FDA). There is no way you can get around doing the three tests. Other tests may or may not need to be conducted.
Fri, Apr 29, 2011 - 02:20 pm
60 Minutes
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Optimizing Ultrasound Systems using Integrated Receivers
* TGC noise analysis techniques will be presented to aid designers in determining receiver noise contributions in near and far field B mode imagining. * The key IC performance specifications that determine PW Doppler mode sensitivity will be discussed. * Analysis of the CW Doppler signal path critical noise sources and suggested filtering techniques will be presented.
Thu, Mar 31, 2011 - 12:00 pm
60 Minutes
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Taming the Complexity of Smart Products with Systems Engineering
66% of products developed in the past year included some kind of embedded information technology. But what does this dramatic increase in complexity mean for the creators of those products? Discover how systems engineering can help manufacturers reduce design errors and speed development, while collaborating in real-time with far-flung design partners. Examples from industry will be presented to aid in understanding the ROI of this approach. Register now, it’s FREE.
Wed, Mar 23, 2011 - 01:00 pm
60 Minutes
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Portable Power for Medical Devices
As the medical world becomes ever more portable and field-responsive, the need for smaller, lighter, and untethered devices is becoming more important. Many manufacturers of portable medical devices have upgraded their medical devices to operate on Lithium ion (Li-ion) battery technology, while others still use older battery technologies such as Nickel-cadmium (Ni-Cd), Nickel Metal Hydride (NiMH) and/or Sealed Lead Acid (SLA) in their products. This webcast outlines the options available to medical device manufacturers in Li-ion battery technologies. This webcast will educate electrical and mechanical engineers of portable medical equipment about the different design advantages and use constraints of Li-ion batteries, while examining the chemistry tradeoffs between various battery choices. Registrants will gain insight on how to implement a battery solution that will enable differentiation in this increasingly competitive market.
Mon, Feb 28, 2011 - 10:00 am
30 Minutes
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Breakthrough Devices for the Diagnosis and Treatment of Skin Cancer
This webcast will focus on two cutting-edge technologies related to medical devices in skin cancer research. Melanoma is the leading cause of skin cancer in the United States with 68,000+ new cases annually and 8,700+ deaths. The average patient can have a high rate of survival if the skin cancer is diagnosed and treated early enough. This webcast will discuss how several leading universities in the United States (Georgia Tech, Johns Hopkins University, and Georgia Health Sciences University) are addressing the deadly potential of melanoma by helping to diagnose and treat the disease in its earliest stages of development. The researchers at these universities have dedicated their time and efforts to developing new medical devices that could potentially save the lives of countless people in the near future. Both of these technologies are available for license and further development at the respective universities’ technology transfer office.
Tue, Feb 22, 2011 - 11:00 am
30 Minutes
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Advanced Assay Technologies and Development Methods
Various market reports and studies have concluded that the future for immunoassays is a mixed bag. In the clinical laboratory, mature assays will show moderate growth while emerging assays will fuel most of the growth in this IVD segment. However, all immunoassays will have to pass the test of medical research to demonstrate their contributions to improving patient outcomes. For example, increased knowledge of disease physiology derived from molecular biology and human genome studies will enhance the position of analytes used in chronic conditions such as cardiovascular disease, autoimmune disorders, and diabetes. The function of genes is measured by the presence of tangible products, such as proteins of every size and molecular structure. Thus, immunoassays combined with DNA probe studies will have an important place in post-genomic medicine. This Webcast features presentations by Neal Siegel, PhD, Chief Scientific Officer, Sword Diagnostics; Scott Dylewski, PhD, Senior Scientist, Alverix Inc.; and Nick Gee, PhD, CEO/CSO, Innova Biosciences Ltd. The Webcast concludes with a live Q&A session moderated by Richard Park, Editor-in-Chief of IVD Technology magazine. All attendees will receive a copy of our special DX Directions report on Advanced Assay Technologies.
Wed, Jan 26, 2011 - 02:00 pm
60 Minutes
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Technological Advances in Implantable Devices
Join the content teams of MD+DI, MPMN and OrthoTec for a Virtual Conference and Trade Show dedicated to cutting-edge trends in the design of implantable medical devices. The combined virtual conference and trade show offers the opportunity to learn from industry experts, thought-leaders, and technology providers direct from your desktop. The Implantable Devices Virtual Conference features a full line-up of interactive sessions focused on orthopaedic and cardio applications directly followed by Q&A opportunities and panel discussions. Topics covered include: * Power Management * Innovative Materials * Implant Acceptance * Infection Prevention
Wed, Jan 26, 2011 - 11:00 am
Multiple Presentations
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PLM Systems for Managing Medtech Complexity: Embedding Regulatory Compliance and Quality Processes within the Product Innovation Engine
The world’s leading medical device companies are focused on delivering new products that improve patient outcomes and enable the medical community to deliver the best possible patient care. In today’s competitive environment, product innovation alone is not sufficient for sustaining company growth. Medtech companies must also find ways to streamline their product development processes and build predictable product-supply capabilities. Fortunately, advanced information technologies are making it possible for medtech manufacturers to build robust enterprisewide systems for managing complex regulated activities ranging from product innovation and manufacturing to sales and marketing. In this FREE Webcast, “PLM Systems for Managing Medtech Complexity: Embedding Regulatory Compliance and Quality Processes within the Product Innovation Engine,” hosted by MX magazine and sponsored by Dassault Systèmes, industry experts discuss how life sciences companies are leveraging product life cycle management (PLM) solutions to manage the complexity of regulated processes while also promoting innovation and growth. Who should attend: Executive and senior management involved in IT, product design, regulatory compliance, manufacturing, and quality systems initiatives.
Tue, Dec 14, 2010 - 11:00 am
60 Minutes
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IEC 62304 for Medical Device Software Development: Steps to Compliance
Complying with the IEC 62304 standard for medical device software requires an established software development lifecycle process. However, compliance does not need to slow down your medical device development. Key steps can be taken to identify gaps in your process today and actions can be implemented to help get through regulatory approvals faster. You can also reap the benefits of lower costs and deliver high quality safer devices. This is the second in the series of webinars that will take a deeper dive into IEC 62304 to identify key steps, best practices, and best of breed integrated tooling to help companies conform to IEC 62304 on the way to FDA and international approval of their medical device.
Wed, Dec 8, 2010 - 01:00 pm
60 Minutes
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Ethylene Oxide Sterilization
This webinar is designed to acquaint those in the medical device community with the appropriate ways to develop, optimize, and validate an ethylene oxide sterilization process. The properties and hazards associated with ethylene oxide and the process required to successfully validate a medical device will also be discussed. The validation methods used are outlined in ANSI/AAMI/ISO 11135-1:2007. Some of the related testing includes comparative resistance, bioburden resistance, bioburden enumeration, sterility testing, sterilant gas residues, and temperature/humidity distribution studies. In addition, the batch release method will be outlined. This process allows the manufacturer to sterilize a single lot of product for use in clinical trials or animal studies where large numbers of samples are not available. This provides a rapid and cost effective way to provide sterile product without undergoing the full validation process.
Fri, Dec 3, 2010 - 09:00 am
60 Minutes
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