Donawa Maria
Donawa Consulting, Rome, Italy.
Med Device Technol. 2006 Apr;17(3):29-31.
The development of comprehensive accurate and well-organised technical documentation that demonstrates compliance with regulatory requirements is a resource-intensive, but critically important activity for medical device manufacturers. This article discusses guidance documents and method of organising technical documentation that may help avoid costly and time-consuming duplication.
编制全面、准确且条理清晰的技术文档以证明符合监管要求，对医疗设备制造商来说是一项资源密集型但至关重要的活动。本文讨论了有助于避免代价高昂且耗时的重复工作的指导文件和技术文档组织方法。
