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ON-DEMAND WEBINAR





ON-DEMAND WEBINAR

Single-Use Endoscopes: Critical Safety and Regulatory Considerations for Manufacturers

Published Date: December 15, 2023

The transmission of infections via endoscopy remains a critical concern due to the inherent design challenges of scopes. Single-use endoscopes offer a pivotal solution by eliminating the risk of patient-to-patient contamination. However, manufacturers face key safety considerations in bringing these products to market for medical use. This webinar discusses laboratory testing and terminal sterilization considerations and steps to help ensure compliance with regulatory requirements within the US and EU. Key topics include:

  • Product and packaging design
  • Material compatibility with sterilization modalities
  • Microbiological testing and process validation considerations to ensure a desired sterility assurance level is met
  • Regulatory compliance, including compliance with ISO 13485 and adherence to the requirements of US and EU regulatory agencies

Learn more about the presenters below.

Gregory Grams

Gregory Grams

Sterilization Expert

Gregory is a Sterilization Technical Director with Sterigenics. He is responsible for the development of new cycles, customer validation, and R&D projects. He is a leader in validation, development, and cycle design and improvements. Gregory is an active trainer who enjoys sharing his knowledge with others through formal seminars at trade shows, as well as informal...

Jordan Elder

Jordan Elder

Regulatory Affairs Expert

Jordan has 15 years of experience navigating regulatory pathways and identifying optimal regulatory strategies for pharmaceutical and medical device companies. As Director of Regulatory Affairs for Regulatory Compliance Associates (RCA) he is responsible for providing clients with general direction, tactical objectives, and functional plans for their regulatory needs. Jordan is a meticulous regulatory professional with...

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David Gilbert

Department Scientist, Sterilization

David “Gib” Gilbert is the department scientist of the sterilization section at Nelson Labs. He started with the company in early 2004 as a laboratory technician while attending the University of Utah, where he studied mechanical engineering. He worked his way to a study director role and later a consulting study director role. He served in those roles until 2022, when he was made Department Scientist. He is certified through AAMI as a CISS – EO and participates as an AAMI alternate over ISO 11135.

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