Ensuring Compliance with ISO 11607: Guidelines for Medical Device Packaging

ISO 11607 is a crucial standard in the medical device sector, specifically focusing on packaging for terminally sterilized medical devices. From a packaging engineering and quality team perspective, ISO 11607 holds significant importance in ensuring the integrity and safety of medical devices. More over, you must pay attention to key validation steps specific to sterile packaging, such as process validation requirements, equipment qualification, and continuous monitoring of process performance.

To assist you and your team in succeeding on this journey, crucial facts and key details can be found in: Ensuring Compliance with ISO 11607: Guidelines for Medical Device Packaging

• Main requirements of ISO 11607
• Key validation steps specific to sterile packaging
• Practical check list