Qmed Webinars & Online Courses

  • Regulatory Support for Material Compliance

    In today’s high-risk, global business environment, contract manufacturers should seek to ensure that those who design, manufacture, sell, and use consumer products take responsibility for reducing negative impacts to the economy, environment, public health, and worker safety. This webinar explores the important role product stewardship plays in reducing the health, safety, environmental, and social impacts of a product and its packaging throughout all lifecycle stages, while minimizing time to market and maximizing economic benefits.

    Wed, Sep 23, 2015 (All day)


  • Keys to Optimizing a Compliant Medical Device NPI Process

    Medical device manufacturers face the challenge to deliver innovation while complying with strict and vital global regulations, but the good news is that extensive documentation required for medical device compliance can now be managed and delivered electronically to streamline, optimize and harmonize the New Product Introduction (NPI) processes. Join CIMdata’s President Peter Bilello, Epic Medical Concept’s Vice President & COO Peter B. Lucas, and Arena Solutions’ Product Marketing Manager Ann McGuire for a webinar highlighting the keys to optimizing a compliant medical device NPI process.

    Tue, Sep 22, 2015 - 02:00 pm


  • Assurance of Sterility and Sterility Assurance Levels: What’s in the Future?

    Currently there is an initiative in the ISO technical committee on sterilization of healthcare products to develop a standard which discusses assurance of sterility. As the content for the ISO standard is developed to represent current and future industry thinking worldwide, several topics have been discussed in detail which we’ll review in this webinar.

    Tue, Sep 22, 2015 (All day)


  • Resolving the Thermal Challenges of Medical Device Design

    During this webinar we’ll review the solutions available to manage concentrated heat loads, reduce noise, reduce fouling/bioburden to minimize HAI risks, meet IEC-60601 touch temperatures, lower component temperatures, and improve reliability. Technologies discussed include heat pipes, vapor chambers, thermal ground planes, phase change materials (PCMs), microchannel/porous metal liquid cold plates, advanced solid conduction materials, thermoelectric and compressor-based refrigeration systems, and thermal interface materials available for assembly.

    Tue, Sep 15, 2015 (All day)


  • Smart Choices in Medical Device Coatings

    Join Dhruv Patel, Product Manager, Coatings Technology of Biocoat Inc., as he covers the design inputs, manufacturing process, performance testing and FDA parameters currently of concern. Costs, chemistry and consistent results will be examined in an unbiased manner. You will learn about: what concerns to address for a variety of substrates, a clear view into the manufacturing process and how to determine costs and an in-depth view of the differences in coating options available today.

    Thu, Sep 10, 2015 (All day)


  • Updates & Trends from FDA; Including Recent ISO 10993 Biocompatibility News

    Thor Rollins, biocompatibility expert with Nelson Labs, will provide insights on biocompatibility testing and where the ISO/TC-194 working group plans to take the ISO 10993 standard in the future, and Allison Komiyama, regulatory consultant with AcKnowledge Regulatory Strategies, will break down the FDA’s recently released “A-list” guidance documents and discuss how recommendations may impact medical device manufacturers.

    Tue, Aug 25, 2015 - 02:00 pm


  • Performance Capability of a New Small Chamber Ethylene Oxide Sterilizer

    This webinar will review the features and performance capabilities of a new, fully programmable small chamber (5 cubic feet or 8 cubic feet) ethylene oxide sterilizer system. Find out how this sterilizer for in-house and contract sterilization provides flexibility in cycle design, chamber uniformity, is engineered for safety, has detailed record keeping and also meets standards requirements.

    Thu, Aug 20, 2015 (All day)


  • Making Traceability Work for the Business: Effective eDHR and UDI

    Most medical device companies are faced with a challenge. They have a growing number of new products and an increasingly dynamic global supply chain but at the same time, regulators demand robust device history records (i.e., eDHR) and UDI labeling and traceability. This webinar will show you how to satisfy regulators, reduce costs, improve quality and foster continuous improvement through modern and consistent manufacturing information systems.

    Tue, Jun 30, 2015 - 08:00 am


  • Transformational Factors Affecting Reprocessing Durability for Re-usable Medical Devices

    New trends in cleaning, disinfection, and sterilization of reusable medical devices present new challenges in designing products that meet customers’ expectations for life expectancy in the field. It also requires innovative approaches to qualification protocols that can accurately reflect performance. This webinar will give a basic understanding of the chemicals and operating conditions of commonly used reprocessing procedures. Case studies will share how design and material choices can affect sterilization durability of the final product.

    Thu, Jun 25, 2015 (All day)


  • How to Pick the Best Materials for Your Mobile Health Device

    Thanks to the rapid development of wireless connectivity technologies, health devices have become increasingly mobile and accessible not just at hospitals and clinics, but also at home. Applications have been developed so that patient data are instantly available from wearables, phones and computer tablets. Remote monitoring and other types of health devices leveraging mobile technologies have been proliferating and the trend will continue to gain momentum in next 10 years. The value is tremendous in improving patient outcome and reducing healthcare costs. This webinar will discuss the opportunities and challenges for device manufacturers as they craft mobile product development strategies.

    Wed, May 20, 2015 - 11:00 am


  • Learning from Hospital Acquired Infections (HAIs): Understanding Current Reprocessing Regulations, Product Validation and Clinical Human Factors

    Watch this exclusive on demand webinar where it will provide an overview of Hospital Acquired Infections, human factors issues encountered in device design and in the healthcare facility, and how to perform a validation for a reusable medical device for use in the healthcare facility. Information on test procedures as well as US and EU regulatory requirements, including new guidance from FDA, will be provided.

    Tue, May 19, 2015 - 08:00 am


  • 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