Medical Device Parts Supplier Meets ISO 13485

Main Category: Medical Devices
Article Date: 26 Feb 2008 - 4:00 PDT

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Precision metal stamping company Meier Tool & Engineering (MTE) has been certified to ISO 13485 2003 standards. This ISO standard represents the requirements for a comprehensive management system for the design and manufacture of medical devices. Specializing in prototyping and production of miniature parts and assemblies for the medical device industry, MTE is one of only a few metal stamping companies to be ISO 13485 2003 compliant.

In being compliant, Meier Tool & Engineering meets specific requirements for inspection and traceability of parts used in implantable devices; documentation and validation of processes for sterile medical devices; and verification of the effectiveness of corrective and preventive actions. These are just a few of the complex manufacturing, documentation and quality procedures in ISO 13485 2003.

MTE engineers have successfully converted parts as small as the head of a pin from expensive manufacturing processes like production machining and metal injection molding (MIM) to the extremely tight tolerance and cost-effective metal stamping process. Metals that are expensive and hard to machine are good candidates for this conversion process. These include titanium and stainless steel alloy components for laparoscopic, endoscopic and arthroscopic instruments. By converting the manufacturing process to precision metal stamping, both piece part costs and lead-time are dramatically reduced. Meier Tool & Engineering not only meets ISO 13485; they also implement lean methodologies, real-time video inspection technology, sensors, and SPC to monitor and control processes and drive continuous improvement.

About MTE

Meier Tool & Engineering Inc. is a privately held custom, precision metal stamping company that has been meeting the needs of the medical device industry since 1979.

To learn more about Meier Tool & Engineering's capability, visit http://www.meiertool.com.

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