Why watch this on-demand webinar
A key focus of the U.S. Food and Drug Administration’s evaluation of a medical device’s safety and effectiveness is reviewing its material makeup. If improperly tested – and impure materials are used – there is an elevated risk of contamination that can produce false results. The already lengthy FDA approval process for medical device manufacturers can be extended dramatically without certified pure materials, which will, in turn, increase the cost of commercialization. When considering porous materials for functional applications including filtration, venting, wicking, applying, and absorbing, these manufacturers should consider those already third party tested to stringent analytical, clinical, and life science procedures.
In this webinar designed for medical device engineers and researchers, the team at Porex will provide a comprehensive overview of Certified Pure Porex® program, a technical performance and medical certification program that provides purity assurance of its porous polymeric materials. Based on extensive experience with many life science applications, they have tiered this program to align with the various FDA requirement classes so that, based on the medical device’s intended application, the proper porous media is selected and tested to an appropriate scale. The third-party testing looks at leachables and extractables, as well as viral and bacterial filtration efficiency. This application-specific purity certification can accelerate your FDA validation timeline and enable a faster device market launch.
When you attend this webinar, you will learn about the:
• Science & importance of material purity in the FDA validation process
• Applications associated with each tier
• Testing procedures associated with each tier
Category Manager – Life Sciences, Porex
Nadia is the Category Manager for Life Sciences solutions at Porex. Nadia has 10 years of international healthcare experience in the areas of Manufacturing, R&D, Operations, Product Development, Marketing, and Business Development. An expert in our sintered and fiber technologies, Nadia leads a global team to develop a robust product portfolio focused on drug delivery for applications such as injectables, inhalation, and topical application. Nadia holds an MBA from the University of Edinburgh Business School.
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