This webinar will explore the significant changes implemented with the release of the Medical Device Regulation (MDR) in the European Union and its impact on packaging requirements. The new regulations have prompted substantial changes within the packaging industry, culminating in the newly published ISO 11607. The presentation will provide a detailed discussion on three key points regarding packaging and how ISO 11607 guides device manufacturers in meeting these new requirements.
Viewers will gain an understanding of the specific changes in packaging regulations driven by the MDR. The session will explain how these changes affect the packaging industry and the implications for medical device manufacturers. By examining the directives of ISO 11607, attendees will learn how to align their packaging processes with the updated standards to ensure compliance and maintain the integrity and safety of medical device packaging.
The webinar will also include a brief discussion on the life cycle approach to packaging validations. This approach ensures that packaging systems are thoroughly tested and validated throughout their entire lifecycle. By the end of this webinar, attendees will have a comprehensive understanding of the new packaging requirements under the MDR and how ISO 11607 helps manufacturers meet these standards. They will learn about the critical aspects of packaging validation, including specific tests and sample size considerations, ensuring their packaging processes are compliant and effective.
This session is essential for packaging engineers, quality assurance professionals, and regulatory affairs specialists involved in medical device manufacturing, equipping them with the knowledge to navigate regulatory changes and implement effective packaging validation strategies.