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ISO 13485 certification is a critical quality standard for medical device manufacturing. A manufacturer certified by this standard provides medical device components and products that meet all proper international compliance requirements and end-user needs. Marlin Steel has earned ISO 13485 certification as of April 2024 so that customers can be confident in our wire and sheet metal fabrication products for medical device applications. Learn more about ISO 13485 certification, its benefits for Marlin Steel and our customers, and our quality stainless steel wire and sheet metal medical devices.

ISO 13485 Certification: An Overview

ISO 13485 provides guidelines for an organization to design its quality management system regarding the manufacturing processes of its medical devices. Being certified by this standard ensures the manufacturer’s medical devices comply with regulations to deliver quality patient treatment. ISO 13485 is based on ISO 9001 quality management systems with provisions for medical devices, lending credibility to manufacturers and peace of mind for medical facilities, such as hospitals and clinics, that use medical devices.

ISO 13485 is internationally recognized and mandated in many countries. The U.S. FDA has proposed a regulation to harmonize ISO 13485:2016 and FDA 21 CFR 820. Marlin Steel is one of the few wire manufacturers that has ISO 13485 certification.

Benefits of ISO 13485 Certification for Marlin Steel

With ISO 13485 certification as of April 2024, Marlin Steel offers several key advantages to our medical industry customers:

  • Improved Quality Control
  • Regulatory Compliance
  • Streamlined Processes, Documentation, and Operations
  • Enhanced Customer Confidence

Premium Wire Manufacturing for the Medical Industry

Marlin Steel produces all products in the USA to ensure fast turnaround times and the highest quality. The medical and pharmaceutical industries depend on our custom-fabricated, precision-engineered, electropolished stainless steel medical devices, which include wire trays, baskets, and disease-control equipment. We can custom design and fabricate a solution to meet our clients’ needs, such as microscopically smooth finishes that can be easily cleaned and sanitized. We use medical grade 304 and 316 stainless steel to construct these wire and sheet metal fabrication forms, baskets, racks, and trays for the medical and pharmaceutical industries.

Certified by ISO 13485 as of April 2024, Marlin Steel delivers consistent custom stainless steel wire and sheet metal fabrication medical devices with the highest precision, quality, and tight delivery schedules. Our advanced wire-forming equipment includes three state-of-the-art welding and forming machines.

Experience the Marlin Advantage, Contact Our Experts Today!

ISO 13485 certification is critical to manufacturing high-quality medical devices. It lends credibility to medical device manufacturers, providing improved quality control, regulatory compliance, documentation, operations, and processes. With our ISO 13485:2016 as of April 2024 and ISO 9001:2015 certifications, Marlin Steel is committed to fabricating medical devices to the highest standards. We work on tight schedules to deliver high-precision stainless steel baskets, trays, racks, and more.

Contact us to learn more about our certifications and metal fabrication capabilities, or request a quote for our medical device products.