Changes to the design of an existing product or the adoption of a new product into a device family necessitate a product change assessment for the existing Ethylene Oxide (EO) sterilization cycle that has been previously validated. This webinar offers guidance on performing a product change assessment in accordance with ISO 11135:2014. The goal is to help limit the extent and costs of validation work while ensuring product safety and regulatory compliance.
Medical device manufacturers developing new products or improving the design, packaging, and load configurations of existing products will benefit from this presentation. Participants will gain a deeper understanding of the requirements of ISO 11135 for product adoption and change assessment. The webinar will explain how to conduct adoption studies for changes in new products, ensuring that all modifications are thoroughly evaluated and meet the necessary standards.
The presentation will also highlight the benefits of product adoption. By following the guidelines set out in ISO 11135:2014, manufacturers can streamline the validation process, reduce costs, and maintain high safety and compliance standards. The insights provided will help manufacturers effectively manage product changes and integrate new products into existing device families without compromising the integrity of the sterilization process.
This webinar is essential for professionals involved in the development and regulatory compliance of medical devices. By attending, participants will be equipped with the knowledge and tools to conduct efficient and compliant product change assessments, ensuring the ongoing safety and efficacy of their products.