Design Control—Integrating The Quality System Regulation and ANSI/AAMI/ISO 13485 Requirements
August 29 - 31, 2018
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.