title: A systems-oriented approach to auditing the design controls process: part 2.
authors.affiliation: Midwest Process Innovation, LLC, Maineville, OH, USA. JGAGL777@One.Net
authors.forename: John
authors.initials: J
authors.lastname: Gagliardi
mesh_terms: D001698:Biomedical Engineering; D004867:Equipment Design / Q000379:methods*; D004864:Equipment and Supplies / Q000592:standards*; D006801:Humans; D015203:Reproducibility of Results