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验证

利用医疗设备制造的过程验证,满足内部和政府要求。确保您的整个系统和 EOL 交付产品满足政府的要求。

验证

数据验证自动化工具

确保产品质量标准

在新的医疗设备上市前,制造商需要高度确定其过程采取了恰当的控制措施,以满足适用的标准和要求。

Lanco Integrated 拥有适用于医疗设备装配系统的验证过程,可满足行业的最高要求。我们工程师所开发的过程符合美国 FDA 和 ISO 13485。过程验证与过程控制并驾齐驱,您还可以从 Lanco Integrated 获得业界领先的指导意见。您将从我们的长期计划和战略中获益。

遵循完整的 GAMP®5 验证过程,其中包括:

  • 设计资格 (DQ)
  • 安全资格 (SQ)
  • 安装资格 (IQ)
  • 运行资格 (OQ)

丰富的行业经验

与全球领导者建立合作伙伴关系

从组建最初的验证团队一直到任何必要的重新验证步骤,我们将一直与您保持合作,协助您制定全面的验证计划。我们的自动系统减少了人工,确保了计划执行的统一性。我们在医疗自动化领域拥有 数十年的专业经验 ,世界各地的医疗制造工厂都依靠我们实现其合规性。

验证

資源

Automotive - Brake Module

Semi - Automatic Brake Module assembly on our Lanco HFL 2002 -S pallet transfer system.

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Commercial Industrial - Sprinkler Assembly

Fully Automated System producing 4.5 Parts per minute with 100% quality Inspection.

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Consumer Products Brochure

Lanco is acutely aware of the importance of time-to-market in the Consumer Products sector and the need to produce cosmetically perfect parts.

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Corporate Brochure

From concept and development to finished product and after-sales service, Lanco Integrated empowers global assembly.

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Corporate Video

Lanco Integrated specializes in creating modular powered and free and cam driven assembly systems designed for future expansion and changes based on customer needs.

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Corporate Video (Chinese Subtitles)

Lanco Integrated specializes in creating modular powered and free and cam driven assembly systems designed for future expansion and changes based on customer needs.

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Covid 19 - How an Automator partnered with customers to tackle Covid

Lanco Integrated 2020 Partnering with customers to tackle Covid on multiple fronts. From diagnostic test kits, sanitizer dispensers and Trigger pumps for disinfectants, Lanco's assembly systems have produced millions of components critical to the fight against Covid.

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Voice of the Customer - Guala Dispensing

Lanco Integrated has been partnering with Guala Dispensing for over 25 years. Guala is the leading manufacturer of trigger sprayers and pump dispensers. Meet Paolo Ratto, the COO of Guala Dispensing. Learn how Lanco Integrated has manufactured reliable assembly systems that keep Guala running full production throughout the year!

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Medical Device Assembly & Validation Services Brochure

Delivering precision solutions for technical medical device and diagnostic requirements, Lanco stands with its customers.

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OKU - German

The cam system is designed to last for decades with regular maintenance.

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Pallet Transfer System

The versatility of the Lanco’s Transfer system makes it easy to adapt as production demands change and grow.

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Pallet Transfer System MPS 120

Lanco Integrated's Mini Pallet Transfer System is a modular transfer platform for material handling, assembly manufacturing and test systems.

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Pallet Transfer System HFL 2002-S

The HFL 2002-S Pallet Transfer System is a modular, non-synchronous transfer platform for material handling, assembly and test systems. It is suitable for creating lean manufacturing cells and building semi or fully automatic systems.

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全球装配专家

我们验证过程的优势

文档验证步骤

美国 FDA 要求您提交进行过程验证的文档。过程验证减少了生成该文档的工作量。此关键步骤将根据您的特定要求而定制。

符合法规

目前,我们的验证过程可帮助公司遵守全球数十家监管机构的严格规定。我们的验证过程包括 DQ、SQ、IQ 和 OQ,以满足相应的 FDA 和 TÜV 规定。

建立合作伙伴关系

借助我们的 整体服务解决方案,我们为您构建的过程验证系统是我们在您成功道路上建立长久合作伙伴关系的基石。在全球高度认可的自动化工程师的支持下生产您的医疗设备,以确保您在所有适用法规的范围内均能获得最高的产量。

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