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

September 5 - 7, 2018

85354 Freising, Germany

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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