This Nelson Labs webinar will delve into the significant changes brought about by the release of the Medical Device Regulations (MDR) in the European Union and their impact on packaging requirements. These new regulations have led to substantial modifications in the packaging industry, culminating in the newly published ISO 11607 standard. This session will provide a comprehensive overview of how these regulatory updates affect medical device packaging and the steps manufacturers need to take to ensure compliance.
The webinar will highlight three key points regarding packaging changes prompted by the MDR. Attendees will gain insights into the specific updates in ISO 11607 that address these changes and learn how the standard guides device manufacturers in adapting their packaging processes. The discussion will focus on ensuring that packaging systems maintain sterility, integrity, and safety throughout their lifecycle, in line with the new regulatory demands.
A crucial part of the presentation will be an exploration of the life cycle approach to packaging validations. This approach ensures that all aspects of packaging are thoroughly tested and validated, from design and development through to routine production. The webinar will provide an in-depth look at a couple of specific tests that are essential for validating packaging systems, offering practical guidance on their execution and importance.
Additionally, the session will address sample size considerations, a vital component of establishing a robust validation testing plan. Attendees will learn how to determine appropriate sample sizes for various tests to ensure statistically significant results that support regulatory compliance.
By the end of this webinar, participants will have a clear understanding of the MDR-driven changes to ISO 11607 and the necessary steps to achieve compliance. They will be equipped with practical knowledge on packaging validations, specific testing protocols, and sample size considerations, ensuring their packaging processes meet the highest standards.