Monthly Archives: November 2022

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. Program Objective  Upon completing this [...]

Event Overview To the casual observer, Sampling Plans can be incredible complex and hard to apply. Worse yet, the subject is a jungle with non-intuitive jargon and crazy acronyms. So why bother? The key advantage is that Sampling Plans can save time, money and resources. It certainly answers the question: “How much is enough?” Sampling [...]