Are you fully optimizing your current fluid dispensing process? True precision dispensing creates better process control throughout all assembly areas. From choosing the right disposable components to fully incorporating your process into a complete system, an objective evaluation of your current process can have noteworthy gains. When accurate deposits are consistently dispensed, significant savings are realized. Let us show you how to elevate your process in order to increase productivity while reducing costs.
Tue, May 20, 2014 - 02:00 pm - 03:00 pm
Overmolding is ideal for projects with complex final molded component designs. In the medical device industry, overmolding offers extended functionality and aesthetic enhancements that can differentiate your product from the competition. However, developing a robust process for achieving these benefits can drive designers and project managers crazy. In this webinar, we will review the primary factors for designing and developing a good overmold solution to take your products to the next level.
Thu, Apr 24, 2014 - 08:40 am - Fri, Apr 24, 2015 - 08:00 am
This webinar will address the details surrounding the new ISO 80369 standards that will soon be implemented in the component manufacturing industry. The expert in this webinar will outline what ISO 80369 standards are and how they will affect the industry. Learn why the industry needs ISO 80369 standards, what the standards are, and when the standards will come into effect.
Tue, Apr 15, 2014 - 08:00 am - Wed, Apr 15, 2015 - 08:00 am
We all know that putting some degree of healthcare into the hands of consumers is imperative for future success. The current climate has created a race between medical device and consumer electronics OEM’s to see who can create the best solutions first. But, the approach taken by these two vastly different industries is what will make the difference between products that have real promise for users and those that will prove to be nothing more than glorified pedometers. How do you create solutions that have clinical relevance but deliver on expectations for consumer usability and price points?
Thu, Mar 13, 2014 - 08:00 am
Whether designing a medical device for an entirely new procedure or improving an instrument for an existing procedure, it is essential to first understand the common practices, expectations, and needs of the various users who will interact with the device. But what do you do with the mountain of observations and insights that result? How do you communicate key findings and opportunities with team members who did not make it out into the field themselves? Reports and specifications can only do so much. Creating a Workflow Map is a much more effective way of establishing a shared understanding of the design problem within your project team and your organization as a whole.
Thu, Feb 27, 2014 - 08:00 am
Strategic interoperability is a critical requirement for medical device companies to integrate and make their devices interoperable with enterprise systems and solutions. In this webinar, we will discuss why standalone “intelligent” devices are no longer sufficient enough to stay competitive in this market. Manufacturers and solution providers want to provide true value to their customers by enabling interoperability that seamlessly integrates data into clinical workflows, and deliver the ability to extract actionable “real-time” quantifiable analytics from device data and unstructured clinical content.
Tue, Feb 18, 2014 - 02:00 pm - 03:00 pm
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
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
In April of 2013 the FDA released a draft guidance on using ISO 10993 for biocompatibility. This draft is intended to replace the #G95-1 document on the current thinking and application of biocompatibility testing for medical devices. In the webinar we will cover three areas of the new document:1. Summary of ideas that are currently practices by the FDA but this is the first instance that they are put in writing 2. Concepts that can be used for justifying testing plans, and 3. New ideas that are not current thinking with the FDA that could change how you are testing.
Wed, Aug 21, 2013 - 01:00 pm
This topic will cover the relevant standards and test methods for face masks, gowns and drapes testing. The webinar will include a summary of what tests need to be performed, how these tests are performed, sample sizes, and estimated turn-around times. The goal will be to provide a starting point that will allow you to put together a testing plan that is right for you, your product, your budget and your timeline.
Fri, Dec 21, 2012 - 08:00 am
How do you sterilize product when you only have enough product produced to make up one sterilization load? How do you demonstrate a sterility assurance level (SAL) of 10-6 when you do not have the time or sample quantity required for a full EO validation? The batch release method is a rapid and cost effective approach to sterilizing single or small batches of product needed for clinical or animal trials with minimal sample requirements. The presentation on batch release testing gives a general outline on the background and requirements on performing an appropriate sterilization validation for these small or infrequently produced lots. The overkill concept, properties of ethylene oxide, and testing requirements will be discussed. The webinar will demonstrate how the sterility assurance level can be achieved and outline all of the necessary testing required to be able to safely release product. The batch release method can be performed in small laboratory vessels as well as at contract sterilization facilities and provides the much needed flexibility to get product to trials or to market without the time and expense of waiting for the completion of a full sterilization validation.
Tue, Nov 20, 2012 - 03:44 pm
Available on Demand
This webinar is specifically directed to cardiovascular medical device manufacturers that will be conducting particulate matter testing on their product. It’s also applicable to anyone that has questions regarding what steps are necessary to develop a testing scheme, what products should be tested for particulate matter and common pitfalls that manufacturers may encounter when submitting data to regulatory for approval.
Thu, Jul 19, 2012 - 08:00 am
Most medical device manufacturers know the importance of sending their product through rigorous cleaning and testing before they release to market. Standard sterility and biocompatibility tests are already an essential part of many manufacturers' protocols. What may not be as commonly understood, however, are the different ways a product can be contaminated during the manufacturing and production, cleaning processes, and packaging of medical devices. To avoid detrimental contamination, manufacturers should test their devices to examine the surface residues remaining on the device after these processes. This presentation on cleaning validations for newly manufactured medical devices and single use implants is a useful guide to help develop a successful test plan to provide cleanliness data. In addition, this presentation gives guidance on industry trends to justify residue limits.Available On Demand
Thu, Apr 5, 2012 - 09:00 am
This on-demand webinar is designed to provide information for the beginner and the intermediate level person seeking further details into performing cleaning validations of reusable medical devices. The webinar covers the fundamentals of the cleaning process and goes into more depth about how to contaminate and perform the dwell time of the devices, what methods are used to clean the devices, what residuals are appropriate to test for specific device types, evaluating the recommended cleaning procedure for a reusable device according to AAMI TIR12:2010 and AAMI TIR30:2003, and the acceptance criteria for each residual tested. This information is needed to assure that once the device has been used, it can be properly cleaned. It is the responsibility of the manufacturer to apply this data, along with their own functionality and sterilization data, to the label claims. Lastly the topic covers several of the standards along with case studies and examples.
Wed, Jan 4, 2012 - 11:32 am
Regulatory Considerations & Revalidation Tests for Managing Change in Packaging Materials or Critical Supplies
When a critical supply for your product or process changes, there are several regulatory items that you should consider. Regulatory bodies, such as FDA, expect that you will be able to show your due diligence in assessing the risk and impact to your product/process. This webinar will provide guidance to navigate through a supplier change for packaging materials by providing a comprehensive approach to regulatory considerations for managing the change. Also included in this webinar is a review of packaging test methods for validation of sterile barrier materials and the testing required as outline in ISO 11607.
Sun, Jan 1, 2012 - 01:04 pm
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