Does your medical device require sterilization? The new ISO 11135:2014 is becoming more recognized as the international standard for the process management and validation requirements of Ethylene Oxide (EO) sterilization.
Medical device manufacturers should compare their current sterilization processes against the new standard requirements and generate a quality plan that includes changes needed to transition to the new version. We'll answer your biggest questions about the new requirements in this 13-page white paper:
- What are the steps of the sterilization process?
- What process and procedure changes are included in the new standard?
- How and where is the new standard recognized?
- What are the new requirements for validation, requalification, equivalence assessment, monitoring and release?
About the Author
Alexandre Pétiard is a Senior Quality & Regulatory Consultant at Emergo. With more than eight years of experience in regulatory affairs, his expertise includes design control support, technical file preparation, clinical evaluation report , risk management file, 510(k), quality system implementation and audits, and post-market surveillance and vigilance activities. Mr. Pétiard previously held regulatory positions at Covidien, Integra LifeSciences, and Alcis.