#2 - 5 key questions every medical device manufacturer should ask Top articles from 2020: A product-centric QMS approach supports continuous improvement, streamlines regulatory compliance, and simplifies validation. ) doesn’t prescribe how to produce a specific device, but states manufacturers “should use good judgment when developing their quality system and apply those sections of the QSR that apply to their products and operations.” It’s the manufacturer’s responsibility to establish the appropriate methods and procedures to design, produce, distribute, and deliver devices meeting these requirements, which involves creating or selecting a quality management system (QMS). The agreement will help customers with Continuous Process Improvement by making use of automated microscopy.