With certification according to DIN EN ISO 13485:2016, we signal to manufacturers of medical devices the safety and reliability of the components and services we supply. Please also visit our new medical technology website: www.hailtec-med.de

You would like to learn more? Sample images and information about HAILTEC MED is provided in our press release:

DIN EN ISO 13485:2016

HAILTEC certified as supplier for medical technology

HAILTEC GmbH from Baden-Württemberg has been successfully certified according to DIN EN ISO 13485:2016. Clients from the medical technology sector can thus rely on the safety and high quality standards of the components and services supplied. As a supplier of filigree metal parts, HAILTEC relies on digital processes in cutting-edge technologies such as ultrashort pulse laser processing.

The international standard DIN EN ISO 13485:2016 regulates the requirements for a quality management system for medical device manufacturers and their suppliers. Compared to DIN EN ISO 9001, ISO 13485 focuses on consistent quality assurance, control of all relevant processes, documentation and traceability. By complying with this new standard, HAILTEC proves that it meets the high requirements, has a functioning risk management system, uses established procedures for quality assurance and hazard prevention, and strives to continuously improve its processes.

Customers benefit from quality and traceability

With this certification, the southern German specialist for precision metal parts qualifies as a supplier and contract manufacturer for medical device manufacturers. It thus assures customers of consistent product quality and can reduce their efforts in the registration of medical devices - for example, by eliminating the need for time-consuming supplier audits. CEO Alexander Renz: "The DIN EN ISO 13485:2016 certification underlines that medical technology manufacturers can continue to rely on the safety of the components and services we supply as well as seamless traceability."

Technologically experienced medical technology supplier

HAILTEC has many years of experience as a medical technology supplier and serves as an extended workbench for many clients. Since 2005, the supplier has specialized in laser fine cutting. The company's extensive technology pool also includes micro waterjet cutting as well as cutting and microstructuring with the ultrashort pulse laser (UKPL). Individual precision mechanical components and precision formed parts, prototypes and samples are created under one roof, enabling HAILTEC to react particularly quickly and control quality all around.

Company information

HAILTEC MED is a brand of HAILTEC GmbH. Smallest parts play the main role at HAILTEC. Since 2004, the family-owned company has been manufacturing laser cutting, punching and bending parts as well as entire assemblies as a subcontractor. One specialty is ultra-short pulse laser processing with femto-laser beams, which HAILTEC is one of the first to offer on a contract basis throughout Germany. From design to tool and fixture construction to the production of prototypes, pilot series and series, the contract manufacturer handles everything at one location. HAILTEC operates its own quality management system, is certified according to DIN EN ISO 13485 as well as DIN EN ISO 9001 and controls its production processes via a modern ERP system.

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Images (Source: HAILTEC GmbH)