Adoption of a new product into a device family or changes to the design and configuration of an existing product requires a product change assessment to the currently-validated sterilization process. This webinar will provide guidance for a product change assessment per ISO 11135:2014 to help limit the extent and costs of validation work, while at the same time, helping to ensure the safety of products and compliance to regulatory requirements.
If you are a medical device manufacturer developing new products or improving the design, packaging and/or load configurations of existing products consider attending this webinar to gain a greater understanding of the:
– requirements of ISO 11135 for product adoption and change assessment
– conduct of adoption studies for changes of new products
– benefits of product adoption
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