Alternatives to Animal Biocompatibility Testing: Possible Changes to ISO 10993

Recently the medical device biocompatibility standards committee (ISO 10993) met to review and discuss proposed changes for hemocompatibility and genotoxicity testing. This webinar will discuss these proposed changes along with chemical characterization, evaluation of leachables, and the effect on the body. These currently require costly and time consuming animal testing; however current testing procedures are being evaluated and in vitro methods are being considered. The presentation will also focus on proposed changes in the ISO 10993 standard and help users be aware and prepare for these changes. Along with the changes, we will discuss the latest points from the ISO committee members on ISO 10993-3 and ISO 10993-4, including:An overview of the testing in ISO 10993-4: Selection of tests for interactions with blood and ISO 10993-3:Inspection and audit timelinesTests for genotoxicity, carcinogenicity and reproductive toxicity, specifically the hemocompatibility and when to perform the direct and indirect methods.The complement activation test and why the FDA has been requiring this test and future considerations.

Wed, Aug 15, 2012 - 02:00 pm

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Biomedical Textiles Enable Device Design

Explore the advantages of biomedical textiles technologies to enable device design. Engineered from polymeric, metallic or resorbable materials, implantable textiles enable advanced designs for high-performing applications such as cardiovascular, orthopedics, neurovascular and general surgery. Biomedical textile engineering blends together advanced biomaterials, textile forming technologies and unique fabric geometries o create flexible, minimally invasive device designs.

Thu, Aug 2, 2012 - 05:00 pm

Duration: available now on-demand

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Particulates: Their Role in the Medical Industry

Particulates that may be present on intravenous medical devices such as guidewires, catheters, and stent delivery systems pose potential health risks to patients. This webinar is aimed toward companies that develop such products or manufacture other cardiovascular medical devices or devices that are likely to come in contact with a patient’s bloodstream. The FDA has frequently requested these devices be tested for particulate matter. General testing methods and validation techniques will be discussed as well as sources of particulate matter, particulate matter monitoring and effectively establishing limits for your device. Available standards and guidance documents such as USP <788>, EN45502/ISO14708 and AAMI TIR 42:2010, will also be a topic in the presentation. Lastly, methods for particulate matter analysis (light obscuration and microscopic) will be discussed along with the advantages and disadvantages of each.

Thu, Jul 19, 2012 - 03:37 pm

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Profitable Paths to Overcome the Conflict between Innovation, Regulatory Shifts and Quality

Most medical device companies are growing, but only a quarter are achieving financial significant business performance improvements at the same time. A new research study by UBM Canon MD&DI and its research partner Cambashi Inc. reveals that “Advancers” who are achieving rapid growth and improving key financial metrics actually have more product variants and are less focused on traditional cost management than others. The Advancers focus more on improving cost of quality -- not just quality-- and managed to improve an array of operational metrics to do so. This webinar session will reveal research results for the first time from the new report

Tue, Jul 17, 2012 - 02:00 pm

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Developing Medical Devices with Safety, Reliability, and Security in Mind

Software is assuming an ever-increasing role in the control of mission critical equipment. This is particularly true for medical equipment. Despite this trend of relying on software to provide safe, secure, and effective system control, very few opportunities exist for engineers to get training and education in even the basic concepts of dependability engineering. Dependability has three primary aspects – safety (freedom from harm), reliability (availability of services), and security (freedom from intrusion, interference, or theft). This talk will dive into these three key pillars of design, particularly on the software side, and provide insight into the interdependencies that make these critical medical devices run.

Wed, Jun 20, 2012 - 11:00 am

Duration: 60 minutes

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8 Step Approach to Address the Multi-faceted Security Threats Targeting Medical Devices

Medical devices, including diagnostic tablet computers, heart-rate monitors, and MRI scanners, are just as susceptible to malware as standard laptop computers. The stakes of keeping healthcare devices secure are particularly high. As the complexity of securing devices increases, so does the risk of vulnerabilities slipping past equipment manufacturers and hospital IT organizations. However, this complexity is reduced significantly when medical devices are designed for security using platforms similar to typical networked clients, such as laptops and workstations. There isn’t a single security solution capable of addressing all existing and future risks; instead, it’s necessary to implement a series of different defenses across the system. Join Intel’s Mike Taborn and Wind River’s Ken Herold as they demonstrate how to address these risks and design security for the medical market. In this webinar, attendees will learn how to:Assess current and future risks and implement a series of defenses across the system to address and protect against known and unknown risksSimplify medical device security management by incorporating standards-based platforms while offering state-of-the-art protectionDeploy safeguards throughout the platform to provide a robust protection against the vast majority of attacks

Tue, Jun 5, 2012 - 12:00 pm

Duration: 60 minutes

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Stand-Alone Medical Software: Understanding Compliance

At the end of January 2012, the European Commission published MEDDEV 2.1/6. This document is designed to provide a frame of reference for stand-alone software under the three medical device directives, which is important for compliance purposes. Many companies coming from a software background are new to medical device regulations and lack the tools for compliance. Since software that assists a medical device in its function also is regulated as a medical device, an understanding of medical device regulation is critical for vendors of software used in clinical settings. In this webcast, Erik Vollebregt, a Dutch lawyer specialised in EU legal matters related to medical devices, will discuss in detail the regulatory issues surrounding stand-alone software and explain how MEDDEV 2.1/6 helps manufacturers achieve compliance and where it may fall short. Attendees will come away from the one-hour session with a clear understanding of compliance as it relates to stand-alone software from a legal perspective.Erik Vollebregt is a founding partner of Amsterdam-based Axon Lawyers, a boutique law firm that focuses entirely on the life sciences industry. He is specialised in legal, regulatory and IP issues involving the life sciences with a focus in biotechnology and medical devices. He also maintains the medicaldeviceslegal.com blog.The one-hour webcast will include a question and answer session and will be moderated by Norbert Sparrow, Editor in Chief, EMDT and medtechinsider.Webcast Details: This pay-per-view webcast will take place on Tuesday, April 24 at 14:00 London/15:00 Paris. Attendance is €99 per person. *Please note: Credit card charges will appear in US dollars. Group rates are also available. Contact Sue Johnson for information: sue.johnson@ubm.com, +1 (310) 740-9013.

Tue, Apr 24, 2012 - 09:00 am

Duration: 60 Minutes

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