Donawa Maria
Med Device Technol. 2003;14(1):26-31.
One of the most difficult decisions that medical device companies may face is whether or not to report an adverse event to regulatory authorities. This article discusses a series of UK vigilance guidance documents for device implants designed to assist manufacturers in making these decisions and the wider value to industry that these documents may have.
医疗器械公司可能面临的最艰难决策之一，就是是否向监管机构报告不良事件。本文讨论了一系列针对器械植入的英国警戒指导文件，这些文件旨在协助制造商做出此类决策，以及它们可能对行业产生的更广泛价值。
