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
This webcast gives device labelers a different perspective on UDI submission. Rather than being an endpoint, UDI submission is the start of a living record – that has a lifecycle. The presentation also examines the long term benefits of UDI data as persistent, living records for use across sectors of the life sciences industry. These UDI records will be a key building block in the drive toward global healthcare interoperability.
Wed, Apr 15, 2015 (All day) - Fri, Apr 15, 2016 (All day)
Learn how new tribologically modified MT® grade copolymers are enabling quiet, smooth-sliding medical parts. The experts at Celanese, will present the latest, innovative material solution, Hostaform® MT® SlideX™ POM, and how it is delivering improved technical properties, easy processability, and increased patient comfort.
Thu, Apr 9, 2015 - 08:00 am
This webinar will highlight the purpose of having a documented validation plan in place prior to performing any package testing. We will also look at regulatory requirements, examine key considerations when designing, manufacturing, packaging, and testing your medical device, and review what needs to be incorporated into each section of the protocol.
Tue, Mar 24, 2015 - 08:00 am
When an idea for a new medical device – or reinvention of an obsolete one – arises, it can be difficult to decide its development and manufacturing destinations. Does your company have the necessary resources to take on that kind of challenge, or is it more economical to begin research on Contract Manufacturers? Essentially do you make, or do you buy? How do you choose?
Tue, Feb 17, 2015 - 08:00 am
This webinar provides a basic overview of considerations for establishing a test strategy and test plans for biocompatibility, sterilization and packaging of healthcare products. We will provide examples of some of the common mistakes which we have experienced regarding test strategies and plans. Lastly we present a practical example of developing a biocompatibility testing strategy. The information is intended to help make the regulatory submission and testing processes as smooth as possible.
Tue, Feb 10, 2015 - 08:00 am
In today’s increasingly complex market, some medical device companies fear stricter regulatory standards will compromise their ability to accelerate innovation. Fortunately, that is not true. Solid design control business practices coupled with a modern product design solution can ensure medical device companies — even those with globally disseminated supply chain teams — achieve compliance without sacrificing accelerated innovation. Join Topera’s Quality Assurance Director Ken Perino and Arena Solution’s Validation Program Manager Yelena Bolton to learn how medical device companies are balancing business and compliance with their design control process.
Wed, Jan 21, 2015 - 02:00 pm
What considerations should a medical device OEM keep in mind when designing a package ready for sterilization and sale to the final customer? This webinar addresses many of the items that a device designer should keep in mind when getting a product ready for presentation to a contract manufacturer. Design for robust device packaging can save hundreds of thousands of dollars in reworked projects and timelines and can eliminate costly field corrective actions.
Mon, Dec 15, 2014 - 08:00 am - Tue, Dec 15, 2015 - 08:00 am
This webinar will examine how the “Big Three” biocompatibility tests (cytotoxicity, sensitization, and irritation) are advancing and what those advancements mean for medical device manufacturers. In addition to the Big Three, course registrants will learn about the in vitro sensitization/irritation testing model, and what is being done to ensure regulators accept in vitro alternatives. Additionally, registrants will receive insight into the value of in vitro testing as a means of reducing testing costs, and accelerating time to market.
Thu, Nov 20, 2014 - 02:00 pm
This webinar will discuss chemical characterization and how these test methods can help evaluate the impact of a change to the overall biocompatibility of the device. Medical device manufacturers will walk away with a better understanding of chemical characterization and how to evaluate changes.
Wed, Aug 13, 2014 - 08:00 am
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
- Rapid Prototyping for Medical Devices - Webcast
- New Approaches to Assessing Biocompatibility for Medical Devices - Webcast
- Five Mistakes That Can Derail Your Product Development Effort - Webcast
- How to Manage Risk Throughout Medical Device Product Development Cycle and Beyond - Webcast
- Common Mistakes to Avoid During Medical Device Product Development - Webcast
- BIOMED Boston - Event