Qmed Webinars & Online Courses

  • Tracking Medical Device Field Inventory

    This webinar is intended for medical device manufacturers of high-value physician preference items (PPI) who employ trunk stock and consignment inventory. In this webinar, John Smith, Director of Supplier Solutions for WaveMark, Inc., will examine the common challenges faced by medical device manufacturers in managing field inventory. He will recommend best practices and review how manufacturers are deploying cloud-based mobile software, enabled by RFID technology, to take control of their field inventory while controlling costs.

    Thu, May 14, 2015 (All day)


  • PC Influences on Embedded Systems

    As x86 systems- processors, memory, and I/O technologies (cables, radio, etc.) have evolved, the embedded world has absorbed these in various forms and in some cases taken an entirely different approach. In this presentation we explore some of the history of x86 influences on embedded systems as well as new approaches and markets that the embedded world has created.

    Tue, May 12, 2015 (All day)


  • Focus on Fundamentals 3-Day Course - Practical Risk Management: How to Integrate ISO 14971 into your Product Development Lifecycle

    Medical device risk management using ISO 14971 has become an industry best practice for medical device manufacturers. Adopting ISO 14971 methodology may become burdensome or complex if elements such as risk planning, risk analysis, risk reporting, and postmarket risk surveillance are implemented poorly. This practical course will highlight key deliverables and how to generate them, reference warning letters and 483s for examples of what and what not to do, and identify when and how to integrate risk management with the typical medical device product development lifecycle. Learn from David Amor, an industry consultant who specializes in helping companies such as Boston Scientific, St. Jude Medical, and smaller startups navigate through FDA remediation activities surrounding risk management.

    Tue, Apr 28, 2015 - 02:00 pm - Thu, Apr 30, 2015 - 02:00 pm

    60 Minutes Per Day

  • Changing Standards for Medical Device Manufacturers

    As a medical device manufacturer, patient safety is likely one of your biggest concerns. And while there are currently no mandatory regulatory requirements (ISO Standards), steps are being taken toward regulation. So what if your current connectors do not meet these new standards? By making a material change to Eastman Tritan™ copolyester, you can create compliant products and improve part development and molding efficiency all while increasing speed to market.

    Tue, Apr 21, 2015 - 08:00 am


  • The Lifecycle of a UDI Record - Submission is only the beginning

    This webcast gives device labelers a different perspective on UDI submission. Rather than being an endpoint, UDI submission is the start of a living record – that has a lifecycle. The presentation also examines the long term benefits of UDI data as persistent, living records for use across sectors of the life sciences industry. These UDI records will be a key building block in the drive toward global healthcare interoperability.

    Wed, Apr 15, 2015 (All day) - Fri, Apr 15, 2016 (All day)


  • New Tribologically Modified POM MT® Grades for Complex Medical Devices

    Learn how new tribologically modified MT® grade copolymers are enabling quiet, smooth-sliding medical parts. The experts at Celanese, will present the latest, innovative material solution, Hostaform® MT® SlideX™ POM, and how it is delivering improved technical properties, easy processability, and increased patient comfort.

    Thu, Apr 9, 2015 - 08:00 am


  • Developing your Packaging Validation Plan

    This webinar will highlight the purpose of having a documented validation plan in place prior to performing any package testing. We will also look at regulatory requirements, examine key considerations when designing, manufacturing, packaging, and testing your medical device, and review what needs to be incorporated into each section of the protocol.

    Tue, Mar 24, 2015 - 08:00 am


  • Make vs. Buy – A Model for Performing this Analysis

    When an idea for a new medical device – or reinvention of an obsolete one – arises, it can be difficult to decide its development and manufacturing destinations. Does your company have the necessary resources to take on that kind of challenge, or is it more economical to begin research on Contract Manufacturers? Essentially do you make, or do you buy? How do you choose?

    Tue, Feb 17, 2015 - 08:00 am


  • Developing a Test Strategy and Plan

    This webinar provides a basic overview of considerations for establishing a test strategy and test plans for biocompatibility, sterilization and packaging of healthcare products. We will provide examples of some of the common mistakes which we have experienced regarding test strategies and plans. Lastly we present a practical example of developing a biocompatibility testing strategy. The information is intended to help make the regulatory submission and testing processes as smooth as possible.

    Tue, Feb 10, 2015 - 08:00 am

  • The Secret to Accelerated Innovation AND Increased Compliance

    In today’s increasingly complex market, some medical device companies fear stricter regulatory standards will compromise their ability to accelerate innovation. Fortunately, that is not true. Solid design control business practices coupled with a modern product design solution can ensure medical device companies — even those with globally disseminated supply chain teams — achieve compliance without sacrificing accelerated innovation. Join Topera’s Quality Assurance Director Ken Perino and Arena Solution’s Validation Program Manager Yelena Bolton to learn how medical device companies are balancing business and compliance with their design control process.

    Wed, Jan 21, 2015 - 02:00 pm


  • Packaging Considerations for Contract Manufacturing

    What considerations should a medical device OEM keep in mind when designing a package ready for sterilization and sale to the final customer? This webinar addresses many of the items that a device designer should keep in mind when getting a product ready for presentation to a contract manufacturer. Design for robust device packaging can save hundreds of thousands of dollars in reworked projects and timelines and can eliminate costly field corrective actions.

    Mon, Dec 15, 2014 - 08:00 am - Tue, Dec 15, 2015 - 08:00 am


  • Biocompatibility: Rethinking the New Big Three (Cytotoxicity, Sensitization & Irritation Testing)

    This webinar will examine how the “Big Three” biocompatibility tests (cytotoxicity, sensitization, and irritation) are advancing and what those advancements mean for medical device manufacturers. In addition to the Big Three, course registrants will learn about the in vitro sensitization/irritation testing model, and what is being done to ensure regulators accept in vitro alternatives. Additionally, registrants will receive insight into the value of in vitro testing as a means of reducing testing costs, and accelerating time to market.

    Thu, Nov 20, 2014 - 02:00 pm


  • The Power of Chemical Characterization to Assess Changes in Your Medical Device

    This webinar will discuss chemical characterization and how these test methods can help evaluate the impact of a change to the overall biocompatibility of the device. Medical device manufacturers will walk away with a better understanding of chemical characterization and how to evaluate changes.

    Wed, Aug 13, 2014 - 08:00 am


  • Optimal Catheter Design: Making the Smart Choices When Selecting Materials and Manufacturing Processes

    Today’s sophisticated catheters have become modern marvels of advanced design and polymer technology. This information-filled presentation will help you make the right choices of materials and production processes to achieve cost and performance objectives of a catheter-based project while avoiding the pitfall of over engineering. Topics include cost/benefit trade-offs offered by different manufacturing technologies and the integration of advanced polymers’ characteristics into the design of next-gen catheters.

    Thu, Sep 26, 2013 - 02:00 pm - Mon, Sep 26, 2016 - 02:00 pm

    60 minutes

  • Microbial Identification: When to Do It and How It’s Done

    Understanding the nature of the microorganisms in manufacturing environments and on or in products is a vital step in medical device and pharmaceutical processing. In this webinar we will discuss the compendial requirements and recommendations regarding:The importance of microbial identification in an environmental monitoring program.How microbial identification is an important tool with gamma sterilized medical device validations in understanding a product bioburden baseline, in defining product families and in determining the frequency of dose audits.How microbial identification can be critical in investigations of environmental excursions, bioburden spikes, sterility failures, Biological indicator (BI) testing and Microbial Limits screening.Information will be included on microbial identification testing at Nelson Labs, from the benefit of sub-culturing organisms to the importance of a Gram stain as part of a polyphasic approach to identification.

    Thu, Aug 29, 2013 - 11:00 am

    45 minutes