Marian Chicago Announces ISO 13485 Certification and Cleanroom Expansion

Marian Chicago is proud to announce it has achieved ISO 13485:2016 certification. This solidifies its commitment to quality manufacturing for the medical industry. A significant milestone like this underscores Marian’s dedication to providing high-quality custom components to medical device customers.

Marian Chicago joins Marian Monticello, Marian Suzhou, and Marian Singapore on the list of locations certified to ISO 13485.

ISO Class 7 Cleanroom Expansion

As part of this achievement, Marian Chicago has expanded its cleanroom manufacturing capabilities with the addition of a new 2,500 sq. ft. ISO Class 7 (Class 10,000) cleanroom. This marks the facility’s second ISO Class 7 cleanroom, bringing total cleanroom space to 4,000 sq. ft. The expansion significantly increases Marian Chicago’s capacity to produce precision die-cut components for diagnostic devices, skin-contact wearables, and other critical medical applications.

This investment highlights Marian’s ongoing dedication to supporting medical product design engineers and manufacturers with high-performance, regulatory-compliant solutions for critical healthcare environments.

What this means for medical product design engineers:

Assured Quality: With Marian Chicago’s ISO 13485 certification, you can be confident in their commitment to rigorous quality management systems for medical device components.
Enhanced Capabilities: The expanded ISO Class 7 cleanroom provides greater capacity for producing precision die-cut parts in a controlled environment. This is crucial for sensitive medical applications.
Reliable Partnership: This demonstrates Marian’s continued investment in capabilities that directly support the demanding requirements of medical device development and manufacturing.

Looking for a trusted partner for your next medical device project? Explore Marian Chicago’s capabilities for precision die-cut components and cleanroom manufacturing.

Take a look at the various quality certifications we’ve earned by location.

Marian Chicago Expanded ISO 7 Cleanroom Space

Marian Chicago ISO 13485 Certificate

Marian’s Custom Medical Die Cutting & Manufacturing Capabilities

Marian is a global leader in manufacturing custom die-cut components. We convert materials across a variety of industries including medical, automotive, battery and EV, consumer electronics, and more.

Within the medical industry, Marian manufactures custom components for applications from wearable medical devices and advanced woundcare that stick to skin, to medical electronic devices used in hospitals and doctors’ offices around the world.

We supply our customers with a turnkey process from material selection and initial prototypes through clinical trials to a final packaged product.

With 13 global locations, our teams have the knowledge, experience, and capabilities to convert thin, flexible materials to high-quality custom solutions to help solve your trickiest manufacturing problems.