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Welcome to the MDM West Presentation Store. Here you can view and download conference and/or show floor theater presentations before, during, and after the event. If you’re looking for a presentation from a specific session that you’re unable to find here, note that it’s likely because the presenter has not provided permission for external use or has not yet shared their presentation with us. Please check back after the event for a more complete catalogue of available presentations.

Global Medical Packaging Consensus Standards Development to Meet Regulatory Requirements

Thierry Wagner (Global Director, Regulatory & Standards – Healthcare, DuPont™ Safety)

Location: 212AB

Date: Wednesday, February 12

Time: 2:00pm - 3:00pm

Track: Sponsored Session

Vault Recording: TBD

Audience Level: All

• The harmonization of EN ISO 11607 with the EU Medical Device Regulation (MDR): we are getting closer
• Future amendments to strengthen packaging risk management in EN ISO 11607
• Key risks to control for maintenance of sterility
• Minimizing the clinical risks at the interface between medical packaging and users: dealing with the new requirement to conduct usability evaluations
• EU MDR requirements for labelling of sterile barriers