Navigating upcoming changes in Chemical Characterization according to revised ISO 10993-18
The revision of part 18 of the ISO 10993 series is now available as final draft and can be purchased from several websites. The new title “chemical characterization of medical device materials within a risk management process” suggests some important changes compared to the previous version
In this webinar the main changes are highlighted including the use of an Analytical Evaluation Threshold (AET) and the importance of accurate identification and quantification of compounds for a subsequent toxicological assessment. In addition, we’ll explain when an Extractables study should be performed, how to design this study and how it differs from a Leachables study.
Wed, December 4, 2019
Duration: 60 Minutes
Sponsored by: Nelson Labs
Testing Requirements for a Successful Medical Device Sterilization Validation
Today there are a range of sterilization techniques used to terminally sterilize medical devices. This webinar will provide a general overview of the requirements for planning and executing sterilization validations. Using two of the more common sterilization techniques, ethylene oxide (ISO11135) and irradiation (ISO11137), we will review in detail the testing requirements underpinning their validation process and how to optimize your testing strategy utilizing case studies.
In addition to the detailed review of these sterilization techniques, we will also discuss the importance of microbiological control, how this can be assessed throughout the production process and its impact on the sterilization outcome for devices.
Wed, November 20, 2019
Duration: 60 Minutes
Sponsored by: Eurofins
Purity Matters: Understanding the Role of Material Purity in False Test Results
When it comes to clinical and analytical laboratory testing, there is no room for error. Patients depend upon accurate diagnosis in order to make informed decisions about their health, and even the most minor discrepancies or uncertainties in test results can create life-threatening consequences. Similarly, analytical laboratories depend on accurate results to ensure the products they test and produce can have the greatest amount of impact on the general population.
Wed, November 13, 2019
Duration: 60 Minutes
Sponsored by: Porex
Practicalities of Switching to Non-Phthalate Plasticizers
In this webinar, medical device professionals will learn how your plasticizer selection can impact the performance of your medical device.
Wed, October 28, 2019 - October 28, 2020(all day)
Duration: 20 Minutes
Sponsored by: Tekni-Plex
How to Prepare for a Major Business System Change
Making a change to your business system is a big decision. Successful technology implementation projects take strategy, time and planning. Whether looking at implementing new business systems for the first time or replacing existing software, there are key factors to consider before deciding to start a project. Uncovering the answers to these questions before starting the software selection process can help with the planning stages, ensuring success with your project.
Tues, October 22, 2019
Duration: 60 Minutes
Sponsored by: Visions33
Considerations for Third-Party Reprocessing of Single-Use Medical Devices
Making a change to your business system is a big decision. Successful technology implementation projects take strategy, time and planning. Whether looking at implementing new business systems for the first time or replacing existing software, there are key factors to consider before deciding to start a project. Uncovering the answers to these questions before starting the software selection process can help with the planning stages, ensuring success with your project.
Tues, October 16, 2019 - October 16, 2021(all day)
Duration: 24 Minutes
Sponsored by: Nelson Labs
Finding solutions for sample preparation at point of care
As molecular diagnostics move to Point of Care (POC), lab-based processes are being adapted. One area that is sometimes neglected is sample preparation and CLIA waiver. In this webinar we will assess the current lab techniques and their suitability to PoC; the range of cartridges currently available; techniques that could be used such as electrowetting and ultrasonics; review the scientific literature and discuss emerging technologies and design strategies. You will come away with a greater understanding and insight into the challenges and opportunities of sample prep at PoC, key resources for achieving CLIA waiver and tips for maximizing the commercial value of your current system.
Tues, September 17, 2019
Duration: 60 Minutes
Sponsored by: Sagentia
Medical PVC Compounds: Non-Phthalate Options
In this webinar, medical device professionals will learn about non-phthalate materials that can be used for medical applications.
Thurs, Sept 4, 2019 – Sept 4, 2020(all day)
Duration: 19 Minutes
Sponsored by: Tekni-Plex
Medical Device Testing Regulatory Updates, Trends and Changes including: FDA, ISO and MDR
This three-day webinar will provide engineers and QA/QC/RA managers with an overview of medical device industry trends, updates, and anticipated changes. Three major topics will be covered in three days, including: biocompatibility assessments, packaging integrity testing, and medical device cleanliness testing.
Tues, August 20 - Thurs, August 22, 2019 - 12:00 pm each day
Duration: 60 Minutes
Sponsored by: Nelson Labs
Transportation and Distribution Testing for Medical Devices
An important, but sometimes overlooked component of a packaging shelf life validation is transportation and distribution testing. This testing is required for all commerce and is an important early step in total package design. This webinar will introduce you to the basics of transportation and distribution testing by explaining why it is important and what a typical distribution test sequence looks like.
Thurs, July 11, 2019 – July 11, 2021(all day)
Duration: 24 minutes
Sponsored by Nelson Labs
In this webinar, medical device professionals will learn what they need to know about flexible PVC compound regulations, so that they can make informed decisions for their specific products.
Wed, June 26, 2019 – June 26, 2020(all day)
Duration: 19 minutes
Sponsored by Tekni-Plex
Materials for Implantable Devices
Selecting the right materials when designing an implantable medical device is critical to funcationality, long-term performance, and patient safety. In this webinar, you will learn about the unique challenges medical device designers must overcome, and how how to select the right TPU grade for your specific in-the-body application.
Wed, June 19, 2019 – June 19, 2020(all day)
Duration: 15 minutes
Sponsored by Lubrizol LifeSciences
Integrator's Guide to SpO2 Solutions
Before adding new parameters to integrated monitoring systems, original equipment manufacturers have several decisions to make. This presentation will help product development engineers and project managers understand the requirements and challenges of integrating pulse oximetry technology.
Thurs, May 30, 2019 - May 30, 2020(all day)
Duration: 20 minutes
Sponsored by Nonin
How to Prepare for EU MDR 2020
In less than one year, the Medical Devices Regulation (MDR) will be fully implemented. As of May 2020, medical device manufacturers that wish to distribute products in the European Union will be required to comply with these new rules. For these organizations, there is a lot to do to prepare in a relatively short time. In this webinar, you’ll learn valuable insight from industry experts and medical device manufacturers on how to be fully prepared for this important regulatory change.
Wednesday, May 29, 2019(all day)
Duration: 60 minutes
Sponsored by etq
Overcoming Design Challenges with Novel Resorbable Biomaterials
This webinar from Secant Group, LLC, a leading producer of resorbable poly(glycerol sebacate) (PGS) resin, offers guidance for overcoming key design challenges with resorbable biomaterials on the journey to commercialization. These challenges include navigating the biomaterials market, identifying the ideal properties of a biomaterial, addressing compliance mismatch, protecting intellectual property, and knowing when to start working with the FDA.
Wednesday, May 1, 2019 - May 1, 2020(all day)
Duration: 36 minutes
Sponsored by Secant Group
Learn how low durometer, thin walled extrusion can contribute to cost efficiencies and safer devices that could help your medical device company keep up with minimally invasive devices.
Wednesday, May 8, 2019
Duration: 50 minutes
Sponsored by Flexan
Looking for a safer, smaller, energy dense battery for your medical device?
Design Engineers are continuing to innovate in the medical device markets; developing smaller, yet more powerful devices. A primary challenge the designers face is how to miniaturize a device around the large batteries previously required for such applications. ZPower has developed the answer. The ZPower silver-zinc rechargeable cell is the smallest, high-energy density microbattery available; enabling a new generation of products, including many new hearable medical device products, by providing over 58 mWh in packages smaller than the collar button of a dress shirt. ZPower batteries are also non-flammable and non-toxic making them the safest way to power next generation medical device products. This webinar is intended to provide design engineers with greater detail on the benefits of integrating ZPower’s rechargeable microbatteries into their own designs and how ZPower can support that effort.
Tues, April 30, 2019
Duration: 60 minutes
Sponsored by: ZPower
Biocompatibility: Applying the New ISO 10993 Standards
A new updated ISO 10993-1 standard came out in Aug of 2018 that drastically changed how we access medical devices for biocompatibility. We're also dealing with the impact of the Medical Device Regulations in Europe. The timing of these two documents has greatly disrupted the medical device industry. In this webinar we will discuss the changes and efficient approaches to navigate through the troubles.
Thurs, April 11, 2019
Duration: 46 minutes
Sponsored by Nelson Labs
A Complaint Management Primer: Compliance-Driven Strategies for Effective Complaint Management
Medical device complaint handling and adverse event reporting has been required since the first iterations of ISO 13485 and FDA guidance for quality systems. Yet, complaint management practices continue to be the top reasons for FDA 483 observations and warning letters. This webinar will discuss strategies for implementing a complaint management process that facilitates gathering, evaluating, investigating and remediating complaints from the premarket stage to closure–and what practices to avoid.
Tues, March 19, 2019
Duration: 30 minutes
Sponsored by: AssurX
Med Tech Trends: Innovation and Adaptation
The medtech industry continues to grow though at a much slower pace than the previous decade. The industry’s long-term outlook is at risk due to underinvestment in digital capabilities, competition from technology and retail companies, and the growing need to demonstrate better outcomes. This webinar will keep you informed of recent trends in the medtech industry to stay competitive.
Thurs, November 29, 2018
