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Luisa Gutierrez replied to the topic Discussion Topic: Post-market surveillance in the forum Device Documentation 8 years, 2 months ago
I agree with the comments provided so far. The importance of post-market surveillance is to provide the necessary information on the product being used by patients and confirming that is maintaining the safety and efficacy of the product. Also, it is crucial to take into consideration the different requirements of the various regions such as US, EU, japan and China (figure on the link below). By taking a look within each respective column with each region for their manufacturing quality-control systems, this assists in maintaining the oversight required to know if product is meeting expectations. In other words, making sure that within the four major MD markets the best post-market strategies are being utilized to support the public health goals within the different system features.