Gilman Byron L, Brewer James E, Kroll Mark W
Annu Int Conf IEEE Eng Med Biol Soc. 2009;2009:5609-12. doi: 10.1109/IEMBS.2009.5333644.
The current design process is a combination of methods from engineering disciplines, government regulatory agencies (domestic and international) and independent certification and compliance companies. The goal of the processes that have been developed is to be certain that a new product meets the users expectations, is safe and effective in providing its claimed benefits. As products have become more complex and particularly with regard to software control it has become increasingly more difficult to determine the safety and efficacy of a product by inspection or after the fact testing alone. In order to improve the ability of designers and auditors to ascertain the safety and efficacy of a product, the use of design controls has been adopted that specify a method of evaluating the design process at several key stages. This paper will describe some of the methods that are used for design controls intending to give the reader an overview of these methods in the context of medical products.
当前的设计过程是工程学科、政府监管机构（国内和国际）以及独立认证与合规公司所采用方法的结合。已开发的这些过程的目标是确保新产品满足用户期望，在提供其宣称的益处方面安全且有效。随着产品变得越来越复杂，尤其是在软件控制方面，仅通过检查或事后测试来确定产品的安全性和有效性变得越来越困难。为了提高设计师和审核人员确定产品安全性和有效性的能力，已采用设计控制措施，这些措施规定了在几个关键阶段评估设计过程的方法。本文将描述一些用于设计控制的方法，旨在让读者在医疗产品的背景下对这些方法有一个概述。
