Understanding adhesion issues is crucial for medical device manufacturers – but it’s also a commonly overlooked factor. Adhesion of a coating to its target surface is a critical element that can dramatically affect medical device performance. Lacking adequate adhesion can cause a variety of problems including delamination, corrosion, electrical failure, and more. In order to have a successful medical device, manufacturers must avoid these complications by understanding and responding to adhesion issues that can arise in a medical device.
Wed, Sep 28, 2016 - 02:00 pm - 03:00 pm
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)
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)
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
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
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)
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
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)
In the competitive landscape of medical devices and the advantages to being first to the market, many are tempted to move into product development at a rapid pace. Moving into product development quickly is full of risks, particularly in the medical technology space where development is heavily regulated and process driven. There are several elements of product development that you must thoroughly understand prior to entering formal medical device development to reduce risk. Do you know what regulatory path is most appropriate? Are you certain of your Freedom to Operate? Will your funding be sufficient to get you to the finish line? Missteps will certainly cost you time and money and might even doom your product altogether. Join us for a webinar that will outline five things that are crucial to the success of your product development effort. We will also look at the implications of moving into formal device development too soon and methods for assessing risk.
Wed, Apr 27, 2016 - 11:00 am - Thu, Apr 27, 2017 - 11:00 am
This course will discuss the foundations of risk and the application of risk management to medical devices before and after market launch. Composed of three one-hour lectures followed by Q&A sessions, the course will cover the evolution of our modern concept of risk and will provide practical guidance on how to minimize risk throughout the product development cycle. The class also will provide a basic introduction to risk management and inductive and deductive risk analysis tools.
Tue, Apr 19, 2016 (All day) - Thu, Apr 21, 2016 (All day)
60-minutes per day
Conceptualizing, developing and bringing a medical device to market can be punctuated with setbacks. This webinar will help you identify and avoid potential issues at every stage during the product development process. Learn about the benefits of using a known signal, range of test devices that can help you meet regulatory requirements, and how to accurately measure physiological parameters.
Thu, Mar 31, 2016 (All day)
This is a practical crash course on 21 CFR 820 and EN ISO 13485:2012, as well as the key focal points for each element and subpart. Whether you're a startup building a Quality Management System (QMS) for the first time or a Fortune 100 medtech company looking for specific help in a QMS area, learn insider tricks from St. Cloud State University Adjunct Professor and top 40 Under 40 consultant David Amor, an expert who has led multiple QMS implementation and remediation projects for large companies and startups alike. This course focuses on the stuff you can't Google and will take a boot-camp approach to implementing and solving many common QMS obstacles.
Tue, Mar 15, 2016 - 02:00 pm - Thu, Mar 17, 2016 - 03:00 pm
60-minutes per day
Companies looking to deliver IoT solutions need the ability to deliver new value added features and services continuously to their customers without compromising product quality. ALM & Virtual Labs improve two key areas for product quality: collaboration between developers in different departments, and automation of development tasks. Attendees will learn why maximizing team collaboration throughout the entire development project is key when speeding up delivery times, how automating processes in test and build management can be achieved with increased traceability, and how operating costs are reduced.
Tue, Feb 16, 2016 - 11:00 am - 12:00 pm
One of pharma’s fastest-growing and highest-profile segments is facing a crisis. Some oncology drugs have demonstrated chemical incompatibility with traditional polymers used in delivery devices. Consequently, the ISMP and FDA have issued warnings for health professionals to stop using closed system drug-transfer devices made with polycarbonate or ABS plastics, which can leak, break, or dissolve following exposure to oncology drugs. Recent tests compare the chemical resistance of these polymers with Eastman Tritan™ copolyester.
Thu, Jan 14, 2016 (All day)
In this presentation from maxon motor, we will review the three things you need to understand when selecting a DC motor drive system. Discover ways to carefully design your application before building it and understand the key specifications of brushed and brushless DC motors, gearheads and encoders.
Wed, Jan 13, 2016 (All day)
- Conformal Coatings for Tomorrow’s Medical Technologies - Webcast
- ISO80369 Standards Bring Changes to Medical Device Companies - Webcast
- Automation in Machining - Webcast
- How to Develop a Risk Based Biological Safety Evaluation Per New US FDA Guidance - Webcast
- 3 Tips for Successfully Launching an Outsourced Medical Device - Webcast
- When Do I Really Need to Perform an Ethylene Oxide Requalification? - Webcast