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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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Scratching the Surface of Biomedical Devices: Characterization of Materials for Medical Devices
Have you ever wondered: "How clean is really clean?" This question is of critical importance during the manufacture of medical devices that ultimately end up in the body. This presentation will provide valuable information about the modern analytical tools that can be used to assess surface cleanliness and surface chemistry. These instruments can provide chemical bonding information, compositional information and information about the lateral distribution of contaminants or defects on surfaces. The measurement methods discussed use various combinations of X-rays, electrons or ions to determine exactly what is present in the top atomic layers of a device. In the context of medical device manufacturing, this information can be critical, since the presence of corrosion, contaminants or other foreign materials can vastly affect the performance, lifetime and biocompatibility of the device. This presentation will give you some excellent background knowledge regarding surface analysis and will also demonstrate the use of several of these techniques to address surface-related issues on medical devices.
Wed, Nov 24, 2010 - 09:00 am - 09:30 am
30 Minutes
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Photocurrent Measurements in Non-Imaging Healthcare Applications
Amplifier design challenges associated with measuring a small photo detector current: The general problem of photodiode current measurement will be discussed, using pulse oximetry and consumer assays as working examples. This presentation will examine the main analog design challenges and root noise causes associated with measuring a small photo detector current while taking a look at the trade-offs of developing an application to maximize the signal-to-noise ratio.
Thu, Nov 18, 2010 - 01:00 pm
60 Minutes
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The Growing Importance of Software in FDA-Regulated Medical Devices - Part 3: Risk Mitigation
The third and final webinar describes what happens when a facility is inspected and how to mitigate the risk of a device recall during the development of the medical device. The focus will be on inspection preparedness, including a review of recent inspections and recalls involving medical device software, and the consequences of not following proper processes and procedures. The webinar includes a discussion of processes and standards that should be considered for medical device development and a discussion of the operating systems, tools and services Wind River offers the medical device manufacturers and how this can reduce development risk, time to market and development costs.
Wed, Nov 17, 2010 - 02:00 pm
60 Minutes
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Microfluidic Applications for IVDs
Register now and receive the Special Report “Microfluidic Applications for IVDs” FREE, a $99 value. Microfluidic devices have emerged as powerful and reliable analysis platforms for proteomic applications and biomarker screening. The goal for clinical biochips and lab-on-a-chip devices is to include sample injection, separation, test labeling, and detection, and to have everything done in a few minutes. Thus biochips make a perfect match for the new wave of tests that rely on gene and protein expression patterns. Microfluidic devices have evolved and have been developed to miniaturize various diagnostic technologies, such as nucleic acid amplification and detection, immunoassays, mass spectroscopy analysis, flow cytometry, and sequencing. This Webcast will feature presentations by Harry Glorikian, Founder and Managing Partner, Scientia Advisors., William W.P. Chang, PhD, Research Scientist, Wako Pure Chemical Industries Ltd., and Jonathan Siegrist, Cofounder, iGlyko Inc. The Webcast will conclude with a live Q&A session moderated by Richard Park, editor-in-chief of IVD Technology magazine. This Webcast will take place on Tuesday, November 16 at 2:00 p.m. EDT (1:00 p.m. CDT, 11:00 a.m. PDT).
Tue, Nov 16, 2010 - 02:00 pm
60 Minutes
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Model Driven Development for Medical Devices
Attend this webcast and learn how a model-driven development (MDD) process can help you:* Analyze and validate requirement early in development when they are the least costly to implement.* Address challenges concurrently, around design guidelines and regulations from the FDA using system and software development best practices that can help create traceability from requirements to design, implementation and test.* Streamline your validation and verification process to help you engineer more reliable medical devices to avoid recalls* Automate delivery of documentation for the design history file to satisfy audit concernsLearn how the IBM® Rational® set of lifecycle management solutions can help you automate your medical device development process with requirements management, system and software modeling and automated model-based testing tools.
Tue, Nov 16, 2010 - 12:00 pm
60 Minutes
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How to Accelerate the Development Cycle Using Concurrent Engineering
Do you wish to:• Speed up development time? • Galvanize Teams with a common goal? • Compress your time to market?In an age where silos and miscommunication can make or break the timely launch of a product, concurrent engineering helps in delivering safe and reliable products, while compressing time to market. Join us for a webcast on the concept of concurrent engineering as Mark Murphy, CEO of Pro-Dex, Inc. and Joe Rotino, VP of RA/QA share their real-world experiences on how concurrent engineering principles are delivering dramatic results in their organization. Concurrent engineering: • Promotes the ability to understand product function and reliability, sterilization and biocompatibility requirements or manufacturing materials and processes • Gives a team a more structured and predictable approach to the entire product development process • Results in shorter more scientific test methods and anticipated final validation results. • Compresses product management timelines and release of the product, without subsequent testing.Learn:• The framework for concurrent engineering in a medical device manufacturing setting • Real-world examples of concurrent engineering in action • Methods for developing the right environment and creating dynamic teams which ultimately enhances this concurrent engineering process.
Wed, Nov 3, 2010 - 02:00 pm
60 Minutes
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ECG and Heart Rate Monitoring Design Techniques
This technical webcast takes an in-depth look at the major design challenges that are commonly encountered with ECG and Heart Rate Monitor Medical Devices. The presentation provides a system overview and examines proven design techniques for controlling noise sources and EMI radiation, and analysis of various heart-monitoring and respiration monitoring functions.
Thu, Oct 21, 2010 - 12:00 pm
60 Minutes
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The Regulatory Lifecycle – Part 2 of Our Series “The Growing Importance of Software in FDA-Regulated Medical Devices”
The second webinar goes into more detail on the medical device regulatory lifecycle. Risk management is a guiding principle in software safety, and COTS software solutions are introduced as a way to decrease product development costs and product safety risks. A typical product lifecycle is used as the context for when and where FDA regulations and industry certifications play a role in the lifecycle. Current standards such as Good Manufacturing Processes (GMP) and emerging new software-specific standards such as IEC 62304 are discussed.
Wed, Oct 20, 2010 - 02:00 pm
60 Minutes
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Your Medical Device Software May Be at Risk
Complying with the IEC 62304 standard for medical device software requires an established software lifecycle process that includes strong support for risk management and safety assessment. However, IEC 62304 compliance does not need to slow down your medical device software development. By applying best practices guidance and process automation, medical device companies can reap the benefits: * Get through regulatory approvals faster * Lower costs * Deliver safer devices Join André Kindsvater, PEng, Donawa Lifescience Consulting and Martin Bakal, Market Manager, IBM at this webcast to gain a better understanding of this standard and how best of breed tools help tie IEC 62304 into the development process.
Wed, Oct 20, 2010 - 09:00 am
60 Minutes
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Activity Monitoring Technology for 21st Century Consumer Healthcare Applications
A state of the art activity monitor (a.k.a pedometer) in the mid-20th century looked like a pocket watch and used a mechanical sensor to increment a hand on display to count steps. Today activity monitors are used for a range of human physiology measurements, including motion, calorie burn, temperature, body fat, respiration and heart rate. This Healthcare-focused webcast provides an overview of the solutions from Analog Devices, and a look at the new generation of activity monitoring device applications that they enable. View this webcast and learn about: * An overview of next-generation activity-monitoring devices: capabilities and block diagrams. * Healthcare technology components supporting a range of sensor schemes: Pressure, humidity, capacitance, motion, temperature, and light. * And more. * Medical-to-medical communications
Thu, Oct 7, 2010 - 06:00 am
60 Minutes
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Web Seminar Series: The Growing Importance of Software in FDA-Regulated Medical Devices - Part 1: Safety First
How Medical Device Makers Can Meet Safety Requirements, Cut Development Costs, and Achieve Time to Market Using Off-the-Shelf Solutions. This web seminar series provides a lifecycle view of software safety and the regulation of medical devices by the Food and Drug Administration (FDA). By leveraging Commercial Off The Shelf (COTS) hardware and software, medical device companies can decrease certification and development time and dedicate more time to product quality and differentiating features. Part 1: Safety First The first webinar introduces the current state of medical software safety and FDA’s increasing interest in software safety. This webinar provides an overview of FDA terminology, concepts, and guidance for medical device software. A basic product development workflow is introduced, and the relationship between various industry standards and FDA regulation is discussed.
Thu, Sep 23, 2010 - 11:00 am
60 Minutes
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How to Achieve Compliance with IEC 62304 for Medical Device Software Development
Complying with the IEC 62304 standard for medical device software requires an established software lifecycle process that includes strong support for risk management and safety assessment. However, IEC 62304 compliance does not need to slow down your medical device software development. By applying best practices guidance and process automation, medical device companies can reap benefits: Get through regulatory approvals faster, Lower costs, Deliver safer devices. Join Dr. David Vogel, founder and president of Intertech Engineering Associates Inc., and Martin Bakal, Market Manager, IBM, at this Webcast to gain a better understanding of this standard and how best of breed tools help tie IEC 62304 into the development process. Moderated by Sherrie Conroy. Register today!
Wed, Sep 22, 2010 - 10:00 am
60 Minutes
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How to Avoid Meeting a Federal Prosecutor: Compliance with brand promotion policy to avoid litigation and what to do if you do meet a prosecutor.
How can how device and drug makers avoid getting caught in the crosshairs? Over the past few years, several of the biggest manufacturers have come under intense scrutiny for illegal brand promotion and paid billions of dollars in fines. These settlements came after years of investigations by federal prosecutors who rely on a steady stream of employee whistleblowers to uncover wrongdoing. Learn needed insights from Michael Loucks, a litigation partner at Skadden Arps, former Acting U.S. Attorney and First Assistant U.S. Attorney for the District of Massachusetts, where he led major criminal and civil investigations, as well as many of the most high-profile health care fraud prosecutions of the past two decades. Moderated by Ed Silverman. Register today!
Tue, Sep 14, 2010 - 12:00 pm
60 Minutes
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