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    Note: If a device requires premarket notification clearance or approval it can ONLY be listed AFTER the premarket submission [510(k), PMA, PDP, HDE] is cleared or approved. If this is your only device listing, please do not register your establishment until after your premarket submission is cleared or approved. If your premarket submission is cleared or approved, you will need to do the following to list your device: Enter the premarket submission number Enter the proprietary name(s) Identify the activities that you perform on or to the device If your device is exempt from premarket notification/approval, you will need to do the following: Obtain the product code. You may click here to find your product code. Leave the premarket submission number blank Enter the product code in the filter box and click on "Filter" Select the radio button next to the product code and click "Continue" Identify the activities that you perform on or to the device Enter the proprietary name(s) For Initial Importers (facilities that take first title to a device imported into the United States): On the "Identify Manufacturers" page, click on the "Search & Add Products" button. Identify the manufacturer by using either its device listing number, establishment registration number, or establishment name and address. On the next page, under the registration information that matches the manufacturer of your devices, select the devices that you are importing and click on the "Add Selected Products" button. Certify that all the information is correct and click on the submit button. When prompted, enter both the PIN and PCN numbers that you received from the Office of Financial Management for your payment of the establishment registration fee. This information must be entered in order for FDA to accept your registration. If you are not prompted for the PIN/PCN numbers, please send an email to reglist@cdrh.fda.gov. Without entering these numbers, your registration is incomplete. 铮?G   L

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  • 9- 8- 7- 6- 5- 4- 3- 2- 1

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    龙王捕鱼

    时间:2023-03-29 09:26 分享到:

    导读

    随着科技普惠,消费者对产品创新的消费诉求日益上涨。作为连接企业与消费者的媒介,产品创新不仅能为消费者创造更大的附加值,让其有更多购买选择,更是企业赖以生存的根基。


    只有设计未来才有未来,产品力的高低决定企业的核心竞争力,企业的核心竞争力最终体现在独特的产品及服务上。


    1

    什么是产品力?


    产品力,即产品对目标客户的吸引力,通过满足消费者欲望和需求,使之产生购买欲的能力。企业经营的本质就是为客户提供产品,产品力高低决定了企业的核心竞争力。


    打造优秀的产品力需要强大的产品研发能力。研发团队在产品研发阶段定义了产品的基因,决定了产品是否满足客户真实需求、具备良好的用户体验,决定了产品80%的成本、70%的质量;产品所用物料是否更便宜、更可靠的供应,是否更容易、高质量制造出来、更简单快捷进行维修服务,都是由产品研发决定的;也影响着企业运营的复杂度和效率,最终决定了产品全生命周期的利润。


    产品研发不仅仅要攻克技术难关,更应构建以产品在市场上实现商业成功为目标的产品研发管理体系,才能使企业长期拥有更好的产品力。


    以华为公司为例,华为从1996年开始进行自主产品研发,利用3年时间实现了从0到22%的国内交换机市场份额快速增长,但同时毛利率逐年却快速下滑,产品开发周期是业界领导者的两倍还多,投入大量资金研发的新产品要么在上市之前就被取消、要么就是上市后无法获得利润,与国外跨国公司的差距越来越大。


    为了寻求研发管理变革,提升产品力,华为在1999年开始导入IPD研发管理体系,并在2013年正式推行,经过5年实践,研发周期平均缩短50%、产品故障率减少95%。总结华为20年IPD变革历史,IPD帮助华为从89亿到8900亿的销售收入增长,打造了从偶然成功到可复制、持续稳定高质量的管理体系,提升了产品力,实现了商业成功!



    2

    金蝶云·星空PLM

    帮助企业提升产品力


    金蝶云·星空PLM,以IPD(集成产品研发)管理思想为核心框架,帮助企业建立以客户为中心,以市场为驱动,以客户需求为导向的研发管理体系,通过需求管理、产品规划、研发项目及产品数据管理等应用,提升企业创新能力,打造更好的产品力。


    2.1  需求管理与产品规划


    需求管理的目标是精准把握市场需求,通过对收集的需求进行分析进行结构化、标准化、量化的定义,一方面可以更透彻、更全面地理解市场需求,另一方面使需求在企业内与产品有关的人员都能得到准确一致的理解。


    通过产品战略规划(SP)、年度商业计划(BP)及立项开发流程(Charter流程),对需求进行梳理,筛选出符合企业战略目标的产品,削减没有市场机会的产品,集中资源投入到优质项目中,开发出爆款产品。


    ?? SP/BP流程管理及产品路标定义

    按照市场管理流程(MM流程),定义并执行SP/BP流程,在流程执行过程中,提供$APPEALS等工具和方法,辅助企业从多个维度进行市场需求分析,形成潜在项目项目清单,并通过PDC投资组合分析,形成产品路标规划,以产品路标(Offering)及版本火车(Release)索引产品全生命周期过程中的各种数据,指引企业具体产品的研发、销售等业务开展。


    ?? 高质量的产品立项流程

    定义高质量的Charter开发流程(等同于立项流程),并通过CDT团队(商业计划书开发团队)执行;通过Charter流程,将Offering分解为更加详细的定义路标Release,明确产品迭代顺序;经过Charter开发流程,向PDT团队输出结构化的产品业务计划书及项目任务书,在项目任务书中包括初始产品包需求信息、项目里程碑节点计划、项目投资预算、重量级团队等关键信息,以便后续研发项目作为输入数据。


    ?? 实现研发/供应链/制造的联动变更

    通过CAD集成接口,实现图纸修改与BOM修改的联动,避免出现图纸与BOM不一致的情况发生,同时当存在借用的情况时,实现一处修改、处处修改的批量变更效果;同时自动通知供应链/制造环节单据的负责人,对相应单据进行处理;对被变更的物料执行特殊采购策略或禁止采购的限制。针对变更对象可自动创建新版本,实现版本与变更流程的对应关系,便于质量追溯。

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