请问ivd行业如何，做销售怎么样？ 题主今年应届毕业生，考研数学没上线。 目前四六级已过。 收到了四川亚中的入职邀请，做ivd销售，但据那天去一起面试的都是一些开放本科的，甚至不要求学位证。 … 显示全部 关注者 18

罗氏、雅培、贝克曼、西门子四大IVD巨头在化学发光领域均推出了具有竞争力的最新产品，这些产品在检测通量、速度、灵敏度及智能化管理等方面各有优势，体现了外资企业为捍卫中国市场所做出的技术升级与创新努力。 以下是对四家公司最新化学发光产品的详细测评： 罗氏诊断：cobas e 801电 ...

IVD产品进入欧盟市场需获得CE认证，由欧盟委员会DG SANTE部门统筹，成员国CA与NB机构执行符合性评估；监管标准从IVDD过渡至IVDR，新法规强化安全与临床要求，产品分类更细化，CE认证覆盖36国及部分东南亚国家。 1. CE认证与欧盟监管体系

Overview The Model recommends guiding principles, harmonized definitions and specifies the attributes of effective and efficient regulation, to be embodied within binding and enforceable law. Its main elements refer to international harmonization guidance documents developed by the Global Harmonization Task Force (GHTF) and its successor, the International Medical Device Regulators Forum (IMDRF).

Technical report of the fourth meeting of the WHO Strategic Advisory Group of Experts on In Vitro Diagnostics, 2022 (including the fourth WHO model list of essential in vitro diagnostics (EDL 4)). This report also includes the applications received for the EDL 4 and a summary of the deliberations and recommendations by the SAGE IVD members and the methodologist that assessed the supportive ...

IVD（体外诊断）产品的自检实验室在环境和设施方面有以下特殊要求： 1. 洁净环境 洁净度：需达到ISO 14644-1标准，通常为ISO 7或ISO 8级，以减少微粒和微生物污染。 温湿度控制：温度一般控制在20-25°C，湿度在30-60%，确保实验条件稳定。 2. 生物安全 生物安全级别：根据实验类型，需符合BSL-1或BSL-2 ...

The EUL procedure is developed to expedite the availability of IVDs needed in public health emergency situations. It is intended to assist interested procurement agencies and Member States on the suitability for use of a specific IVD, based on a minimum set of available quality, safety, and performance data.

As part of the WHO pre- and post-prequalification product review process, WHO’s Prequalification Unit conducted a special (for-cause) inspection of the quality management system (QMS) at the Manufacturing Sites from 14 to 16 October 2025. A for‑cause inspection is a non-routine inspection triggered by specific concerns or evidence of potential non‑compliance or product quality issues.

先说结论：从仪器角度来说，未来IVD行业最稀缺的是：系统性人才。 系统性人才： 1、了解客户端应用场景和用户使用习惯； 2、了解IVD行业产品的商业模式和盈利模式，基本知晓各产品的盈利水平； 3、了解行业竞争对手的基本情况，能进行竞争产品的分析； 4、熟悉常用仪器原理，自主研发仪器的 ...

This document intends to provide guidance to countries on methods for developing and updating national lists of essential in vitro diagnostics (NEDL). It describes the best practices for selecting categories of in vitro diagnostic (IVD) tests for an NEDL, consistent with the evidence-based methods used to update the WHO Essential Diagnostic List (EDL).