In January 1990, FDA published Device Recalls: A Study of Quality Problems (55 FR 21108, May 22, 1990). The study reported that 44% of quality problems were attributed to errors or deficiencies that ...
Medical device manufacturers have a bit of latitude in developing a design control system as long as they meet the minimum criteria delineated in the quality system regulation (QSR). The QSR states ...
A Protection and Control (P&C) design package for a typical substation includes a number of interrelated drawings, including one-line diagrams, schematic diagrams, wiring diagrams and interconnection ...
With five years of experience as a writer and editor in the higher education and career development space, Ilana has a passion for creating accessible, relevant content that demystifies the higher-ed ...
Why does anything have to change? A manufacturing company’s most critical product decisions are made every day in design reviews. And if you assess the state of what a design review looks like today, ...
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