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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: 2:00 pm - 3:00 pm

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