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Welcome to Team NB | Team NB | team-nb.org Reviews
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1 about us
2 members
3 links
4 presentation
5 question
6 pascaleperspectives
7 team nb position papers
8 documents
9 nb med documents
10 latest news
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1

About us – Welcome to Team NB | Team NB

http://www.team-nb.org/about-us

For 2016 our aims are:. Team-NB is actively pursuing transparency for notified bodies in Europe. Encouraging the continuous improvement and development of products, allowing patients increased access to safe yet innovative devices. Active involvement and support for the completion of the new Medical Device and In-Vitro Diagnostic Regulations. Develop effective communications to ensure our members receive the latest information on all regulatory developments, including guidance, regulations and standards.

2

PascalePerspectives – Welcome to Team NB | Team NB

http://www.team-nb.org/author/pascaleperspectives

This author has not yet filled in any details. So far PascalePerspectives has created 95 blog entries. In the framework of the new Medical Device Regulations,. In the framework of the new Medical Device Regulations,. July 18th, 2016. Concerning the adoption of MD draft regulations by ENVI group TEAM-NB Press Release. July 8th, 2016. On the basis of members data are available in documents 2016. May 17th, 2016. Article in Clinica by Amanda Maxwell. Article in Clinica by Amanda Maxwell. November 4th, 2015.

3

Scrip Regulatory Affairs “Two EU notified bodies join international pilot to test common submission format for devices” – Welcome to Team NB | Team NB

http://www.team-nb.org/scrip-regulatory-affairs-two-eu-notified-bodies-join-international-pilot-to-test-common-submission-format-for-devices

Scrip Regulatory Affairs Two EU notified bodies join international pilot to test common submission format for devices. 2 Notified bodies joined a pilot program that is being run by the International Medical Device Regulators Forum to test a common electronic submission format for reviewing device submissions. Share This Story, Choose Your Platform! In the framework of the new Medical Device Regulations,. ENVI Committee of the European Parliament confirmed agreement on medical device and IVD regulations.

4

Team-NB Position Papers – Welcome to Team NB | Team NB

http://www.team-nb.org//team-nb-position-papers

TEAM NB Draft PositionPaper Authorized Representatives Audit 1. We use cookies to ensure that we give you the best experience on our website. If you continue to use this site we will assume that you are happy with it.

5

Clinica “EU notified body numbers still yet to bottom out “ – Welcome to Team NB | Team NB

http://www.team-nb.org/clinica-eu-notified-body-numbers-still-yet-to-bottom-out

Clinica EU notified body numbers still yet to bottom out. NB withdrawals are due to three reasons, she said:. Not being able to conform to new regulations;. Following a joint assessment or competent authority audit; and/or. Share This Story, Choose Your Platform! In the framework of the new Medical Device Regulations,. ENVI Committee of the European Parliament confirmed agreement on medical device and IVD regulations. Medical devices : deal reached on new EU rules.

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招聘职位

http://www.qimmiq-med.com/Job.aspx

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葵美医疗器械

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ISO 13485 与ISO9001 差异审核服务. ISO 13485 与ISO9001 差异审核服务.

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葵美医疗器械

http://www.qimmiq-med.com/Index.aspx

ISO 13485 与ISO9001 差异审核服务.

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葵美医疗器械

http://www.qimmiq-med.com/FuWu-117.aspx

ISO 13485 与ISO9001 差异审核服务.

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EAAR | Links

http://www.eaarmed.org/links

European Commission Working Groups. European Commission, National Competent Authorities. European Commission Consumer Affairs Medical Devices. European Commission Consumer Affairs Medical Devices Legislation. European Commission Consumer Affairs Medical Devices Guidance Documents. European Commission Consumer Affairs Medical Devices Interpretative Documents. European Commission Consumer Affairs Medical Devices Consensus Statements. European Commission Consumer Affairs Medical Devices Borderline Documents.

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links - qarad

http://www.qarad.com/links

The new ISO 13485: the 2016 version. The official website of the European Commission. Http:/ ec.europa.eu/health/medical-devices. The portal to European Law. The official website of the European Union with links to the publications in the Official Journal. Http:/ eur-lex.europa.eu. The European Committee for. Http:/ www.cen.eu. The International Organization for. Http:/ www.iso.org. The European Committee for Electrotechnical Standardization. Http:/ www.cenelec.eu. Http:/ www.team-nb.org.

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上海久顺企业管理技术服务有限公司

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电话:021-58600065 58600042 58859994 传真:021-58857798 网址: www.isosh.com.

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上海久顺企业管理技术服务有限公司

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美国上市康辉控股 中国 公司顺利通过FDA QSR820的评审. 乐普医疗 300003 、九安医疗(002432)等17家自由销售证书 CFS 注册项目启动. 品牌价值超1.6亿美元的上市公司- -亚洲第一的乔山健康科技顺利通过ISO13485 PAL认证. 三类医疗器械- 3L医用集团ISO13485 ISO9001 CE项目顺利通过认证. 云南白药集团股份 无锡 ISO13485 ISO9001 CE项目顺利通过认证. 傲胜国际 (OSIM International)顺利通过ISO13485 ISO9001认证. 西门子 SIEMENS 威迪欧电机公司顺利通过ISO14001 ISO9001认证项目. 上海柘中 集团 的药监局生产许可证 产品注册证项目启动. 贝联特种金属制品的ISO13485 ISO9001 ISO14001 TS16949整合项目启动. 日本安积滤纸 株式会社 顺利通过ISO9001 2008 ISO14001 2004认证. 英国脱欧后,关于我们 Lotus Global Co.,Ltd 做为贵司的欧代,是否还有效.

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项目管理

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Welcome to Team NB | Team NB

To improve communications with all stakeholders. To promote high technical and ethical standards. To participate in improving the legal framework. To represent Notified Bodies. To contribute to harmonization. Scrip Regulatory Affairs Two EU notified bodies join international pilot to test common submission format for devices. 2 Notified bodies joined a pilot program that is being run by the International Medical . Clinica EU notified body numbers still yet to bottom out.

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