title: Improving product introduction through effective design reviews.
abstract: The design review process is a part of the manufacturer's due diligence in developing a safe and effective product. Design review provides early and on-going independent feedback to developers. By adopting a proactive review process, design improvements can be pursued at an optimum time in the product development effort, i.e., when it will cost less to implement changes and when these changes may have the greatest impact. Effective implementation of the design review requirement will lead to better medical products and improved product introduction results.
authors.affiliation: St. Vrain Group, Inc., Boulder, Colo., USA. pelnik@stvrain.com
authors.forename: Tammy M
authors.initials: TM
authors.lastname: Pelnik
mesh_terms: D001709:Biotechnology / Q000295:instrumentation / Q000379:methods / Q000458:organization & administration*; D003659:Decision Making, Organizational; D004867:Equipment Design / Q000379:methods* / Q000592:standards*; D004864:Equipment and Supplies / Q000592:standards*; D040541:Marketing / Q000379:methods; D011786:Quality Control; D013673:Technology Assessment, Biomedical / Q000379:methods / Q000458:organization & administration*; D014481:United States