The Medical Device Manufacturing Certification Adds to the Company’s ISO 9001:2015 Certification
BALTIMORE, Md.: As of July 29, 2024, Marlin Steel has earned ISO 13485:2016 certification, the standard that specifies quality management system requirements for medical device manufacturing. This achievement certifies that Marlin Steel’s quality management system meets standards for manufacturing wire and sheet metal medical device handling products.
Marlin Steel has been manufacturing custom wire and sheet metal components since 1968. The new certification expands their capabilities to serve the medical device industry.
“Marlin Steel’s ISO 9001:2015 certification and existing quality initiatives, such as our Quality Engineered Quick™ philosophy, demonstrate our commitment to delivering high-quality products with fast turnarounds,” says Drew Greenblatt, CEO at Marlin Steel.
“Achieving ISO 13485:2016 certification for medical devices builds on this foundation. It will allow us to deliver compliant products with enhanced quality, improving patient care. Healthcare facilities and end-users can rest assured that our custom wire forms protect sensitive medical instruments during cleaning, are easy to transport, and resist corrosion,” says Drew Greenblatt.
About Marlin Steel: Founded in 1968, Marlin Steel fabricates custom metal forms, such as racks, component washing baskets, S-hooks, and sheet metal containers. The privately-owned company works with customers in diverse industries, including medical, telecommunications, automotive, aerospace, and food processing. All products are 100% made in the U.S.
To learn more about the ISO 13485:2016 certification, please visit.
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