Qmed Webinars & Online Courses

  • ISO80369 Standards Bring Changes to Medical Device Companies

    This webinar will address the details surrounding the new ISO 80369 standards that are affecting medical device manufacturers. The expert in this webinar will outline what ISO 80369 standards are, how they will affect the industry, and when the standards will come into effect.

    Mon, Sep 12, 2016 (All day)

    30 Minutes

  • Automation in Machining

    Automation is becoming a key component of the industry and should be a heavily weighted factor in selecting vendor partners. Whether utilizing a highly automated cell complete with 8-axis robots and vision inspection capabilities, or a simple solution through fixturing or palletization, automation provides the following key benefits: higher throughput, higher utilization rates, reduction in labor costs, reduction of opportunity costs and process repeatability and consistency.

    Tue, Sep 6, 2016 (All day) - Wed, Sep 6, 2017 (All day)

    20-minutes

  • How to Develop a Risk Based Biological Safety Evaluation Per New US FDA Guidance

    This three day course will incorporate the new US FDA guidance on biocompatibility into the three main steps in developing a Biological Safety Evaluation (BSE): Biological Evaluation Plan (BEP), Testing Options, and Biological Evaluation Report (BER). Composed of three one-hour presentations followed by Q&A sessions, the course will cover each step in developing a BSE in detail. This course will provide insight into regulatory expectations when it comes to evaluating device safety.

    Tue, Aug 30, 2016 - 02:00 pm - Thu, Sep 1, 2016 - 03:00 pm

    60-mins per day

  • 3 Tips for Successfully Launching an Outsourced Medical Device

    Launching a medical device is easy as 1-2-3. Right? Well, it’s not exactly that easy. There are key items you’ll want to consider for successfully launching an outsourced medical device, on-time and within budget. This webinar will identify how to select the right contract manufacturer to ensure the success of your device launch, explain why it is crucial to start planning the device packaging early in the design process, and outline the steps necessary to keep your product launch on schedule and on budget. If you are part of a design or new product team, you won’t want to miss it!

    Wed, Jul 27, 2016 - 11:00 am - Thu, Jul 27, 2017 - 11:00 am

    15-minutes

  • When Do I Really Need to Perform an Ethylene Oxide Requalification?

    One of the first questions that comes to mind after completing an EO sterilization qualification is, "When do I need to perform a requalification study, and what will that study entail?" Maintaining the validated state of a sterilization cycle and ensuring the process consistently and continually delivers the desired SAL is of utmost importance. This presentation takes a comprehensive look at the typical validation approach, the factors that determine when requalification is necessary, and how the expectations in ANSI/AAMI/ISO 11135 have changed in recent years regarding requalification.

    Thu, Jul 21, 2016 (All day)

    30-minutes

  • Rapid Prototyping for Medical Devices

    Learn how rapid prototyping enabled by digital manufacturing can help you shave weeks or even months off the medical device development process. We will explain how utilizing process such as 3-D printing, CNC machining, and low-volume manufacturing, you can reduce manufacturing costs, decrease prototyping lead times, minimize risks, and beat the competition to market.

    Wed, Jun 22, 2016 - 11:00 am - Thu, Jun 22, 2017 - 11:00 am

    30 minutes

  • New Approaches to Assessing Biocompatibility for Medical Devices

    Literature research and chemical characterization tests are increasingly becoming alternatives when it comes to reducing biocompatibility testing on animals. In fact, considerable progress is being made in the development and standardization of new in vitro test methods—particularly when it comes to cytotoxicity, sensitization, and irritation, the basic tests performed for any medical device regardless of the device's application. These alternative in vitro methods provide multiple benefits, including a smaller sample amount, less time required to perform the test, and reduced animal use.

    Thu, May 19, 2016 (All day) - Fri, May 19, 2017 (All day)

    30-minutes

  • 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)

    30-minutes

  • 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)

    30-minutes

  • 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

    60-minute