ISO 13485 Medical & Pharmaceutical Wire Forms: Precision-Engineered for Sterility and Compliance

Engineered for Full Compliance & Process Optimization

At Marlin Steel, our facilities and quality management are ISO 13485:2016 and ISO 9001:2015 certified. This means we produce consistent quality across all medical device products at any volume. By working with us, you benefit from:

• Full material traceability. Every order includes Mill Test Reports (MTRs) for 304 and 316 stainless steel to ensure grade purity.
• Certified sterility. Our electropolished finishes achieve microscopically smooth surfaces for efficient sanitation, eliminating pits where bacteria can hide.
• Safe manufacturing. All products are 100% free of BSE/TSE, melamine, and latex.

Our medical and pharmaceutical wire baskets are designed for maximum longevity on your production line or over repeated sterilization processes. That’s because our products come with:

• FEA stress analysis. Before manufacturing begins, your design undergoes 3D Finite Element Analysis to ensure it withstands heavy loads and high-heat autoclaves.
• Robotic precision. We achieve as tight as 0.031” tolerances through advanced robotic welding, so that every basket seamlessly integrates with automated handling systems.
• Durable metal construction vs. plastic. Unlike polymers, our medical-grade steel won't absorb chemicals, crack under heat, or degrade over time.

Case Study: Delivering Life-Saving Precision in Under 72 Hours

During the COVID-19 pandemic, a major Midwest-based health provider sent Marlin Steel an emergency order at 6:15 p.m. on a Friday night for COVID-19 test tube racks. “It was a design we had never made before,” said Drew Greenblatt, president of Marlin Steel.

“We asked for volunteers to work all weekend, so we could ship ASAP to save lives,” said Greenblatt. “Our team is amazing—we finished before 1:45 p.m. on Sunday.” When flights were canceled, we put the order on a truck to ship it 1,100 miles to ensure it arrived by 8:00 a.m. Monday morning. As this case study highlighted in The Washington Post, we deliver mission-critical process infrastructure when it matters most.

High-Performance Products

Sterilization & Autoclave Trays

Examples of standard products we can customize for sterilization applications include:

• Product #02306001. Electropolished 316 stainless steel basket with a hinged lid and dividers to hold pouches. Optimized for high-pressure steam.
• Product #00147017. Ultra-fine woven mesh basket with a sheet metal-reinforced frame and heavy-duty carrying handles.

High-Capacity Material Handling

Examples of standard products we can customize for material handling applications include:

• Product #00147011. 300-lb weight capacity basket for bulk component storage.
• Product #02306002. Cleanroom-ready rolling cart with a passivated finish and U-channels to hold baskets.

Start Your Engineering Consultation

Marlin Steel’s medical and pharmaceutical wire baskets are 100% made in America under an ISO 13485:2016 certified quality management system. We can customize wire form baskets to meet your unique performance requirements. To discuss your specific application, contact us or request a quote today.