Navigating through the complexity of ISO 11607 for medical device packaging
Speaker: Lisa Heilemann, Head of Quality Management and Validation, Quality Management Representative (QMR)
Date: 10 September 2026
Time: 15:00 - 16:00 CET
Join Eurofins for a webinar on ISO 11607, the internationally recognized standard for packaging validation of terminally sterilized medical devices. This session will provide an overview of sterile barrier system requirements, packaging material selection, compatibility with sterilisation processes, and validation activities including IQ, OQ, and PQ. Key topics will also include package integrity testing, transport simulation, and ageing studies used to support shelf-life claims, helping participants better understand the requirements for ensuring compliance, product quality, and safety.
📌 In this webinar, you will learn:
- Key principles and requirements of ISO 11607.
- Packaging material selection and sterilization compatibility.
- Packaging validation activities: IQ, OQ, and PQ.
- Package integrity and performance testing methods.
- Transport simulation and shelf-life assessment.
- Strategies to support compliance, product quality, and patient safety.
👤 Who Should Join?
This webinar is intended for professionals involved in the safety and regulatory compliance of medical devices, including:
- Packaging and Validation Engineers
- Quality Assurance and Quality Control Professionals
- Regulatory Affairs Specialists
- R&D and Product Development Teams
- Manufacturing and Process Engineers
- Medical Device Manufacturers involved in sterile packaging systems
In Summary:
This webinar provides an overview of ISO 11607, the international standard for packaging validation of terminally sterilized medical devices. Participants will learn the key requirements for sterile barrier systems, including packaging material selection, compatibility with sterilization processes, and validation activities such as IQ, OQ, and PQ. The session also covers package integrity testing, transport simulation, and shelf-life studies to ensure product quality, patient safety, and regulatory compliance.