Marian Chicago is proud to announce it has achieved ISO 13485:2016 certification, solidifying its commitment to quality manufacturing for the medical industry. This significant milestone underscores Marian's dedication to providing high-quality custom components to its medical device customers.
WEST CHICAGO, Ill., July 8, 2025 /PRNewswire-PRWeb/ -- Marian Chicago announces their achievement of ISO 13485:2016 certification. By achieving this certification, Marian is dedicated to quality manufacturing for the medical industry including applications in wearables, rapid diagnostic testing, and more. This milestone proves 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
While cleanroom manufacturing isn't new for Marian Chicago, being certified to ISO 13485 now allows the team to take on projects with more stringent cleanliness requirements. Along with this new certification, Marian's Chicago location has also expanded its cleanroom manufacturing capabilities with a new 2,500 sq. ft. ISO Class 7 (Class 10,000) cleanroom. The addition of the location's second ISO 7 cleanroom brings Marian Chicago's total cleanroom space to 4,000 sq. ft, and this expansion allows for significant improvements to manufacturing capacity.
This investment in Marian's medical capabilities highlights our dedication to supporting our current and future medical customers with high-performance, regulatory-compliant solutions for critical healthcare environments.
This new certification and cleanroom space translates to many additional benefits for customers including:
- Assured Quality: Marian Chicago's ISO 13485 certification means 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, 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.
Take a look at the various quality certifications we've earned by location.
Marian is a global leader in manufacturing custom die-cut components 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. Learn more about Marian's manufacturing capabilities in the medical space.
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.
Media Contact
Lynn Zeheralis, Marian, Inc., 1 317-638-6525, [email protected], marianinc.com
SOURCE Marian, Inc.
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