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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!
March 16 @ 11:00 am
Biocompatibility is no longer a checkbox approach and as the technology behind devices becomes more advanced, so too much the evaluations used to assess medical devices.
January 15 @ 11:00 am
When developing a medical device, the preclinical evaluation process can appear to be a daunting challenge. Many decisions need to be made, which can lead to numerous questions. Join us […]
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 […]
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 […]
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 […]
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
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 […]
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 […]
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 […]
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, […]
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 […]
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 […]
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 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.
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