随着我国经济体制改革的不断深入和对外开放、对内搞活政策的逐步实施,商品经济的竞争、企业之间的竞争,将越来越激烈。以质量求生存,以品种求发展,这将是每个企业生死攸关的首要任务。企业必须使产品质量精益求精和不断推出适销对路的新产品,才能在竞争中立于不败之地。反之,则将被淘汰。医疗器械虽是特殊商品,它要讲经济效益,亦要讲社会效益。但是,它既属商品,因而也回避不了商品经济竞争的规律。近几年来,我们行业经过企业管理的整顿和推行全面质量管理,总结了新产品研制管理方面的一般规律,又根据医疗器械产品批量小、更新快的特点,制订了“医疗器械新产品研制管理程序”。通过三年来的实践, With the continuous deepening of the reform of China’s economic system and the gradual implementation of the policy of opening up and invigorating the country, competition in the commodity economy and competition among enterprises will become increasingly fierce. To survive by quality and to develop by variety, this will be the most important task for each company. Enterprises must keep improving their product quality and constantly introduce new products that are marketable in order to be invincible in the competition. On the contrary, it will be eliminated. Although medical equipment is a special commodity, it must talk about economic benefits, but also talk about social benefits. However, it is not only a commodity, it can also avoid the rules of commodity economy competition. In recent years, our industry has undergone enterprise management rectification and implementation of total quality management, summed up the general rules for the development and management of new products, and in accordance with the characteristics of medical device products with small quantities and rapid updates, has formulated a new product development management for medical devices. program". Through three years of practice,