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Michael A. Swit, Esq. (Principal, Law Offices of Michael A. Swit)
Kim Walker (Vice President of Regulatory, Quality, and Clinical Affairs, Hycor Biomedical)
Vinay Goyal (Project Engineer , Johnson and Johnson Enterprise Product Stewardship)
Valynda Machen (Principal Medical Research Manager, Regulatory, NAMSA)
Date: Wednesday, February 7
Time: 8:30am - 10:00am
Pass Type: Conference (Paid) - Get your pass now!
Conference Track: MD&M: Regulatory & Quality Update
Vault Recording: TBD
The May 26, 2017, date for official entry into force of new European medical device and IVD regulations has been reached, paving the way for full implementation of these regulations in 2020 and 2022. By May 26, 2020, medical device manufacturers active in Europe must be fully compliant with the new regulations. The five-year countdown to the IVDR’s date of application (May 26, 2022) has also begun. This session will cover what you need to know to meet compliance deadlines.
Topics to be covered include: