Obelis Attends Inauguration of CURAM (Center for Research in Medical Devices)

Obelis Chief Compliance Officer, Mrs. Sandra Ferretti, participated in the official inauguration of CURAM – Center for Research in Medical Devices, which took place on Monday, the 26th of Septemb [...]

MEDDEV 2.7/1 – new guidelines on clinical evaluations

On the 29th of June 2016, the European Commission released a new version of MEDDEV 2.7/1, entitled “Clinical Evaluation: A Guide for Manufacturers and Notified Bodies under Directive 93/42/EEC and [...]

EU to release NEW Medical Device Regulations!

In June 2016, the European Parliament released the consolidated texts of the new EU Regulation Proposals on Medical Devices and In-Vitro Diagnostics Devices. The texts, published on the European Par [...]

New Medical Devices and In-Vitro Diagnostic Regulations – Status of the Ongoing Discussions

The approval of the new EU Regulations on Medical Devices and In-Vitro Diagnostics Devices will be postponed to 2016. (more…) [...]



Obelis欧盟授权代表中心(O.E.A.R.C.)在1988年设立于布鲁塞尔。以欧盟的心脏所在处为据点,我们为全球的制造商提供遵循欧盟指令与规章的欧盟授权代表(EC REP)以及CE标示顾问服务。

我们的高质量法规遵循解决方案有ISO 9001:2008与ISO 13485:2003认证背书,包括,但不限于以下各项:

  • 分类
  • 确认欧盟标准
  • 技术文件检查
  • 提交给国家欧盟当局的产品登录与注册
  • 标示法规遵循
  • GMDN代码验证
  • 自由销售证书
  • 商标申请

我们的专业团队拥有专精于医疗器材以及体外诊断医疗器材的知识,能协助您将您的产品推销至欧盟市场,或协助您维持您的产品在欧盟市场内的流通。我们的顾问会引导您通过法规迷宫以及无数的医疗器材指令 medical device directives,以确保您和您的器材能够进入欧盟市场。

现在就联系我们的法规顾问(Contact our regulatory consultants today),让我们协助您完成您的需求。

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