Validation of Sterilization Process for Medical Devices (ISO 11135): From Microbiological Principles to Process Control

Medical device sterilization using Ethylene Oxide (ETO) is a complex and highly regulated process. ISO 11135 provides a comprehensive framework for ensuring safety, effectiveness, and compliance. But how can organizations translate the standard’s requirements into a validated, controlled, and audit-ready sterilization process?

This webinar brings together both a Notified Body expert and a seasoned industry professional to guide you through the key scientific and regulatory elements of ISO 11135 bridging microbiological principles with hands-on process control.

Whether you're responsible for validation, regulatory compliance, or manufacturing operations, this session will help you gain clarity on the technical, operational, and certification-related aspects of ETO sterilization.

Join DQS for a 90-minute live session designed to help medical device professionals understand and apply the requirements of ISO 11135 more effectively. You will learn how to:

• Navigate microbiological considerations in sterilization validation
• Determine gas volumes and optimize load patterns
• Establish effective ETO hold times and critical process controls
• Understand regulatory expectations from a Notified Body perspective
• Clarify common challenges through real-world examples
• Ask your questions directly during the live Q&A

This is your opportunity to engage with leading voices in the field combining regulatory insight with practical know-how.

Speakers:

Klaus Lindenberg
Technical Certifier & Product File Reviewer, DQS
Holds a degree in Biomedical Technology (Diplomingenieur (FH), 1991) from the Lübeck University of Applied Sciences. He has extensive professional experience working with various companies in the medical device sector in Germany. Since 2021, he has been serving as a Lead Auditor and Technical Expert for medical device quality management.

Anil Chaudhuri
CEO, Operon Strategist
Has over 25 years of experience in Regulatory Affairs and Quality Assurance. Trained by US and EU experts, he supports global medical device companies with regulatory strategies, quality systems, and market access bridging compliance with practical execution.

Participation is free. Limited seats available.

Register now - https://attendee.gotowebinar.com/register/6987373755952389724