Webinars
On-Demand Webinar
Ethylene Oxide – Avoiding Pitfalls During Sterilization Cycle Development
Ethylene Oxide (EO) Gas is commonly used in the sterilization of medical devices due to its compatibility with a variety of materials. Understanding what factors are impactful to the validation process will help to avoid pitfalls during the pathway to product launch. The increasing amount of information documents such as ISO 11135 and ISO 10993-7, lay the foundations for development, validation, and routine control. Sterilizing a medical device is one way to ensure patient safety, however it’s important to consider the residual levels left behind from Ethylene Oxide (EO) Gas that make it difficult to predict when a medical device will be safe for release to the public. Another item that must be considered is the microbial load, which impacts the cycle development.
During this webinar, our experts will provide insights into Ethylene Oxide (EO) Sterilization, such as:
- An introduction to EO Sterilization: Why is it important and when is it appropriate for a medical device?
- Factors impacting EO Sterilization, including effectiveness, release, and dwell/aeration times.
- Validation of EO Sterilization from product development through regulatory submission.
- Types of EO Residuals, testing methods, and ISO 10993-7 considerations.
- The FDA’s new ASCA Program – differences and benefits
- An overview of sterility testing, including regulatory requirements and methods.
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On-Demand Webinar
Navigating the Full Biocompatibility Workflow to Ensure Product Safety
Biocompatibility is a critical part of the regulatory approval process for most medical devices. Scientific understanding of biological risks and the tools available to assess them are evolving. Regulatory expectations and guidelines are also changing, adding further complexities to the biocompatibility evaluation process.
In order to avoid delays in the development and approval process, it is important to understand the full biocompatibility workflow needed for each unique device.
During this webinar, our expert will guide you through best practices for performing a biological risk evaluation to current standards, including:
- Developing a Biological Evaluation Plan
- The Importance and Nature of Chemical Characterization
- Toxicological Risk Assessments of chemical characterization data
- Selecting appropriate In vivo and in vitro tests
- The FDA’s new ASCA Program – differences and benefits
- Constructing a Biological Evaluation Report
- Common challenges
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On-Demand Webinar
Principles for Validation of Reprocessing for Reusable Medical Devices - Cleaning, Disinfection, and Sterilization
Reprocessing is a process carried out on a used device in order to allow its safe reuse including cleaning (removal of soil and contaminants), disinfection, sterilization (inactivation of microorganisms) and related procedures, as well as testing and restoring the technical and functional safety of the used device. Due to recent changes in medical device standards and regulations, manufacturers intending to market reusable devices must plan their testing strategy in advance, perform the required tests using state-of-the-art test methods, and evaluate all results in a biological risk assessment document. It is critical to consider proposed changes to AAMI/CDV-2 ST98 and EU MDR, as some changes will require a modified design for cleaning validation. To ensure all requirements are met, close cooperation between various experts, including engineers, analytical chemists, and toxicologists, is necessary.
During this webinar, our experts will provide insight in to:
- Expectations of regulatory authorities regarding the cleaning validation studies
- Details of the test approaches, focusing on the AAMI/CDV-2 ST98 standard and EU MDR
- A high-level overview of requirements for validation of disinfection and sterilization
- How to design the sampling apparatus
- Common feedback from regulatory agencies
Who should attend?
Managers, directors, engineers, and scientists responsible for research and development, product development, quality assurance, and regulatory compliance.
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On-Demand Webinar
Medical Device Package Testing: Avoid Thinking Strictly Inside the Box
Companies are often so keenly focused on developing the product inside the box that they can sometimes miss critical requirements for the package that is intended to protect it. Designing safe packaging that will protect products during shipping and transport, while simultaneously complying with FDA or international health and safety regulations is essential. Developing an appropriate test plan for package performance testing is of utmost importance with the globalization of the medical device industry.
During this webinar, we will share insights and test plans to demonstrate how focusing on the packaging for your product can help to save you time and avoid delays in your product development, including:
- Answers to common packaging questions
- Overview of various testing standards required to get your product to market
- Testing to consider for various shipping methods and techniques
- The current status and expectations of the FDA
- How to design a test plan to meet the supply chain rigors?
Who should attend?
Managers, directors, engineers, and scientists responsible for research and development, product development, quality assurance, and regulatory compliance. As well as, procurement, business leaders, and project management personnel responsible for requesting testing quotations.
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On-Demand Webinar
Biocompatibility Testing of Respiratory Devices as per ISO 18562 – Use of Appropriate Testing and Evaluation Strategies
Due to ongoing changes in medical device standards and regulations, manufacturers of respiratory devices must plan their testing strategy in advance, perform the required tests using state-of-the-art test methods and evaluate all results in a biological risk assessment document. The ISO 18562 series of standards can be used not only for respiratory equipment – such as ventilators and breathing systems – but also for the corresponding accessories, including tubing, masks, y-connectors, oxygen hoods, etc. When there is direct contact between such devices and the patient’s body, the device must be evaluated by ISO 10993 in addition to ISO 18562. To ensure all requirements are met, close cooperation between various experts – including engineers, analytical chemists, and toxicologists – is necessary.
During this webinar, our experts will provide insight in to:
- Expectations of regulatory authorities regarding the biological evaluation plan
- Details of the test approaches, focusing on the ISO 18562 series of standards
- A high-level overview of the toxicological and biological risk assessment of the test results
- How to design the sampling apparatus
- Common feedback from regulatory agencies
Who should attend?
Managers, directors, engineers, and scientists responsible for research and development, product development, quality assurance, and regulatory compliance.
