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

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