经营环节是医疗器械产品生命周期的重要组成部分,但是受限于医疗器械流通的特点,如产品品类和规格众多、经营模式复杂、流通集中度低、地域性强等,医疗器械经营质量管理的专业性相对于生产质量管理一直较弱。随着近几年政府对产品上市后监管力度的加大,质量管理能力已经成为医疗器械经营企业发展的重要助推器和必备的核心竞争力之一。本文对多年来医疗器械经营质量管理方面的实践经验进行了总结。
<<Distribution plays a key rolein Medical Device life cycle,and its quality management is critical to the quality of product delivered to end user. However,limiting to medical device distribution characteristicse.g. product variety,complexity of business model,decentralized distribution channel and localized Health Authority supervision,the quality management of medical device distribution isnot so professional as manufacturing. With the reinforcement of medical device post-market surveillance led by China government in recent years,the capacity of quality management has become an important booster for the development of medical device distributing enterprises and essential core competitiveness. This paper aims to share quality management experiences of medical device distribution based on years of practice as a marketing company.
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