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Life sciences and clinical instrumentation

Safe special steel production for sterile medical products

Whether hip implant, aneurysm clamp or surgical instruments - for manufacturers of sterile medical technology impeccable product safety is a legal obligation. This is also true for suppliers across the entire value-add chain. Ugitech, producer of stainless steel resistant to corrosion, heat and acid, has now received certification from AFNOR (Association Française de Normalisation) for the EN ISO 13485:2016 standard. Ugitech thus verifiably meets all of the criteria of comprehensive quality management in process design, in training employees for specific applications, in quality control and in the traceability of steel bar and wire for medical applications.

"Successful certification is proof once again that we meet the highest quality standards both in steel production as well as in stainless steel products," emphasizes Marc Marticou, Business Development Manager at Ugitech, a company of the SCHMOLZ + BICKENBACH Group. "EN ISO 13485 qualifies us to deliver our products worldwide in medical technology, allowing us to strengthen our competitive edge."

The leading steel producer is audited annually by independent technical certification associations. Ugitech has received the EN ISO 13485 certificate for the second time in succession. Rooted in the law, the standard is largely identical to the voluntary compliance with the ISO 9001 standard for which the company is also certified. The requirements for quality management, however, are much higher in EN ISO 13485. Medical equipment manufacturers must be able to rely on comprehensive risk analyses being conducted already during the product development phase for optimal fulfillment of the requirements for technology and material technology at all times. By holding specific training measures, the steel producer sensitizes their employees to the high quality standards of steel products used in medical technology. Furthermore, the processes during manufacture are documented - every adjustment throughout the entire lifecycle of a steel product is noted and validated by the customer. This applies, for example, to changes in the delivery chain and to adjustments in process engineering in steel production and machining. By its' comprehensive documentation Ugitech guarantees maximum transparency and product safety. This also ensures that in the unlikely event of deviations in quality the responsible health authorities are informed immediately and the necessary steps can be taken.

Image 1 The EN ISO 13485 certificate qualifies Ugitech to sell their stainless products worldwide to manufacturers of high-quality medical products. Image 2: The corrosion, acid and heat resistant steel bars and wires from Ugitech meet the highest requirements for product safety in medical products for which hygiene is particularly relevant, such as hip implants and aneurysm clamps.

Ugitech S. A. in profile
Ugitech, a SCHMOLZ + BICKENBACH Group company, is one of the leading manufacturers of stainless steel long products in the world. Its main products: billets, bars, wire rod and drawn wire are manufactured in its own steelworks and transformed in its high-temperature rolling mill or at its wire-drawing plants. Stainless steels are characterized by their high mechanical properties. They are used to manufacture many different components, including valves, turbine components, welding rods or surgical instruments. With more than 100 years of experience in steel manufacturing and continuous research in the field of metallurgy, the company guarantees optimum solutions for highly demanding applications to customers in its markets such as the automotive, construction, process, aerospace and space industries, as well as medical technology.

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The SCHMOLZ + BICKENBACH Group is today one of the world's leading providers of individual solutions in the special long steel products sector. The Group is one of the leading manufacturers of tool steel and non-corrosive long steel on the global market and one of the two largest companies in Europe for alloyed and high-alloyed constructional steel. With around 9,000 employees and in-house production and distribution companies in over 30 countries and on 5 continents, the company guarantees its customers a global supply and customer service, and offers them a complete production portfolio as well as sales and services around the world. They benefit from the company's technological expertise, the consistently high product quality around the world and detailed knowledge of local markets.

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