Qmed Webinars & Online Courses

  • Five Key Considerations for Evaluating and Selecting the Most Effective Electronic Quality Management Systems for Medical Device Manufacturers

    Evaluating and selecting a FDA Medical Device compliant EQMS for your organization is a crucial, yet daunting task. Choose incorrectly and you could find yourself with antiquated paper-systems, be forced to hire an army of support staff, and/or be stuck paying outrageous maintenance fees. Choose correctly and you will see great boosts in efficiency and effectiveness, enabling your organization to be leaner and more flexible with the ever changing device market requirements.

    Thu, Nov 19, 2015 (All day)


  • Prototyping and Low-Volume Production for Medical Applications

    Prototyping and low-volume production can accelerate the development of medical devices and quickly launch products to market. We’ll explore what types of manufacturing methods you can leverage in order to reach verification, validation and FDA approvals months earlier than you could previously using traditional manufacturing.

    Tue, Nov 17, 2015 - 02:00 pm


  • Enhancing Medical Device Performance and Reliability with Parylene Conformal Coatings

    During this session, we’ll deep-dive into Parylene coatings for medical devices – how they are applied, how they can enhance performance and reliability for critical technologies including electrosurgical, cardio, neurostimulation devices, pharma containers, stents and infusion components, as well as recent advances in this technology.

    Thu, Nov 12, 2015 - 02:00 pm


  • Water Quality for Pharmaceutical and Medical Device Processes

    Water is one of the most widely used raw materials in the MedTech industry; yet water systems are often overlooked as a source of contamination. Register for this webinar to learn the effects water impurities can have and how to select quality water attributes for processes, system qualification, monitoring, and process controls. Attendees will also gain insight into recovering existing water systems, and proper design for new water systems.

    Tue, Nov 10, 2015 (All day)


  • Best Practices for Medical Device Complaints Handling

    During this session you will learn the industry's best practices for initiating and implementing an electronic complaint handling solution. See how automating a process, from complaint intake through review, investigation, regulatory reporting, and returned product shipment tracking can ensure complaints are handled quickly and efficiently, ensuring your company meets its quality and regulatory compliance goals.

    Tue, Oct 27, 2015 (All day)


  • Designing Diagnostic Tools for the Developing World

    Since 2011, Stratos has been working with the Bill & Melinda Gates Foundation to create a system that can quickly, easily, and affordably diagnose diseases in rural and low income areas worldwide. This session will look at the importance of diagnostics for global health and a new system being developed to meet the diagnostic needs in low-resource settings.

    Wed, Oct 21, 2015 (All day)


  • 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)