医疗制品的全面质量管理和合规

我们实施严格控制的质量管理系统在医疗制品的设计、开发和生产上协助您的产品满足全球市场的要求。

在整个设计和生产过程中该系统导入适当的质量监管,包括供应商选择和资质评定到最后验收和器材追踪。

ITL公司通过以下认证和审计:

我们的质量体系额外添加BSEN ISO 14971, BSEN 62304和 BSEN 62366以确保一个全面合规的框架。

ITL公司严格执行以下欧洲CE标志指令,包括:

  • 93/42/EEC 医疗器械指令
  • 98/79/EC 体外诊断学指令
  • 2006/95/EC低电压指令
  • 2004/108/EC 电磁兼容性指令
  • 2011/65/EU RoHS II 指令

需要帮助的现有客户可直接通过电子邮件联系质量保证部,邮箱地址QA@itl.co.uk

You may also like...

News
Meet Melanie, ITL’s New Sales Representative

We are thrilled to introduce the newest member of our team, Melanie Lombardi, the new Sales Representative for the ITL Group.

Read more >

Resource
Advantages vs Disadvantages of 3D Printing in Research and Development

Despite 3D printing being a relatively young technology, it is fundamentally changing the way we prototype and test medical devices – but what are the advantages? Potential challenges? What impact will it have on medical device manufacturing?

Read more >

Case Study
Endomag

Read how ITL took the SentiMag® system from concept to volume manufacture.

View this case study >

Case Study
Vivacta

Working to develop and prototype a Point-of-Care diagnostic device and microfluidic cartridge.

View this case study >