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Our web seminar broadcasts provide you with front-row access to Toxikon’s scientists. Join us for these educational presentations featuring insights into the science the drives laboratory testing; expert commentary on relevant industry regulation; and practical information you can use in your product development today.
Previously-presented webinars are archived for your reference; watch them at any time from any location!
November 19, 2020 @ 11:00 am
Biocompatibility is a complex and ever-changing topic and this talk will review: What is biocompatibility? How to classify a device and select endpoints for analysis Difference between horizontal and vertical standards and FDA guidance documents Common differences between ISO 10993-1 and FDA expectations Sample preparation for testing What standards are most commonly used for the […]
September 24, 2020 @ 11:00 am
Recent regulatory guidance’s continue to emphasize the need for chemical characterization and extractable and leachable assessments as part of an overall device assessment. Additionally, there is also a need to utilize a risk-based strategy for planning and conducting testing for support of regulatory submissions.
August 27, 2020 @ 11:00 am
When it comes to developing a preclinical testing battery for medical devices, sponsors frequently receive feedback from the FDA indicating, that a “well designed and executed” in-vivo study could provide endpoints to address both efficacy and biocompatibility studies.
February 27, 2020 @ 11:00 am
The increasing diversity of medical devices means the lines between categories becomes less distinct and creating an appropriate risk management plan becomes more complex. Understand the challenges unique to absorbable devices (per ISO 10993-1:2018) and how to navigate the pre-testing process.
October 17, 2019 @ 11:00 am
Toxicological Risk Assessment (TRA), which is based on E&L studies or material composition, is an important tool for assessing the safety of medical devices and designing biocompatibility testing plans. TRA’s can provide adequate evidence for circumventing unnecessary animal testing in the safety evaluation of medical devices.
September 5, 2019 @ 11:00 am
With the ever increasing requirements in medical device regulations about risk management, considering all potential options in your biological evaluation plan (see ISO 10993-1: 2018) can help identify potential hazards in biocompatibility testing as well as determining a path forward when positive results are observed.
June 27, 2019 @ 11:00 am
For reusable medical devices, ensuring patient safety is a shared responsibility. The ability to render devices safe for re-use is subject to the demands of device design and function, clinical application, and reprocessing execution.
May 30, 2019 @ 11:00 am
A complete biocompatibility evaluation profile is an essential step in gaining regulatory approval of your new medical device. What happens when you find out that the device your company is riding on fails a biocompatibility endpoint evaluation? How could this happen? What are you to do next?
February 21, 2019 @ 11:00 am
Approximately one-third of all medical products developed today are combination products. These devices require a unique approach when applying for regulatory approval. In this hour-long webinar, Michael Dellogono, Ph.D., will discuss how to select the correct testing pathway and what regulatory requirements your device must meet – helping you reduce the time and stress involved […]
January 24, 2019 @ 11:00 am
Breathing gas pathway medical devices such as breathing systems, ventilators, anesthesia systems, nebulizers, and oxygen lines come into contact with patients at a particularly vulnerable point and time. As a result, the exposure assessment for these devices is an important step in the evaluation of device safety and needs to be particularly concerned with airborne […]
November 29, 2018 @ 11:00 am
ISO 10993-1: 2018 released in August and there are a lot of new concepts included as well as the reinforcement of previous ones
November 6, 2018 @ 11:00 am
Learn the basics of developing a Preclinical IND Program to get your drug development program off to a good start.
September 7, 2018 @ 11:00 am
Properly-prepared test articles are critical for accurate biocompatibility testing. What can you do, as a sponsor, to ensure the successful test of your proposed medical device?
November 9, 2016 @ 11:00 am
Sign up below for our TRA webinar. Toxicological Risk Assessment (TRA) has been an important tool in the safety assessment of biomedical device, providing a chemical-based approach which complements a traditional animal-based testing program. The need for TRA is growing and in some cases, will be considered as a means of circumventing animal testing in […]
October 26, 2016 @ 11:00 am
Sign up at the link below to view this webinar, which will assist medical device designers and manufacturers navigate the reprocessing requirements and successfully execute a manual cleaning validation. This program will present various aspects of manual cleaning validation testing: overall considerations, selection of artificial test soil, soil challenge sites and dwell time, cleaning reagents, […]
June 29, 2016 @ 11:00 am
Sign up below for our hemocompatibility webinar. Before being used in humans, medical devices need, in general, to have some testing performed in order to assess their safety profile. This biocompatibility assessment includes various endpoints, among which a certain number are focused on the potential effect on blood – also known as hemocompatibility. This webinar […]
October 6, 2015 @ 11:00 am
Sign up below for our Colorants webinar. A challenge common to all medical device manufacturers is conducting a regulatory submission which is both effective and efficient. Successful submissions with devices that utilize colorants are less likely to go off without a hitch. What exactly is the perspective of the FDA with regard to Colorants in […]
March 12, 2015 @ 11:00 am
Register at the link below to see how new Biologics, Biosimilars, and Biobetters programs using case studies to illustrate strategy choices and the similarities and differences between each program. New biologics are submitted through an IND process similar to small molecules and require a full battery of safety testing. Biosimilars follow a specific pathway, designed […]
November 8, 2014 @ 11:00 am
Sign up below for our webinar on extractable and leachable compounds. Knowing the structure of a chemical compound is of high importance, even at the level of an extraction study, because it’s the chemical structure (a.o.) that will determine its toxicity. Toxikon developed a unique tool, called TOX-RITE (Rapid Initial Toxicological Evaluation) to allow a […]
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