Design Control Requirements—Integrating the Quality System Regulation and ANSI/AAMI/ISO 13485

January 30 - February 1, 2019

Arlington, VA

This intensive 3 - day course provides complete coverage of design control requirements for FDA Quality System Regulation, ANSI/AAMI/ISO 13485:2016, and the Medical Device Single Audit Program (MDSAP). With the participation of FDA representatives during the entire course, attendees have the unique opportunity to participate in a shared learning experience. An optional exam is available online for 2 weeks following the end of the program.

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