Dordan Achieves ISO 13485: 2016 Medical Device Certification

Posted by Chandler Slavin on Apr 1, 2024 10:00:32 AM


Dordan Achieves ISO 13485 Certification, Strengthening its Dedication to Providing High Quality Medical Packaging 

Woodstock, IL, 4/1/24 — Dordan Manufacturing, a leading designer and manufacture of thermoformed packaging like medical device trays, blisters, kits, and assembly trays, proudly announces its achievement of ISO 13485: 2016 certification. This accomplishment solidifies its commitment to meeting the highest quality and regulatory requirements within the medical device industry.

ISO 13485 is an internationally recognized standard developed for organizations involved in the design, production, and servicing of medical devices. The rigorous ISO 13485 certification process involved comprehensive evaluations of Dordan Manufacturing's Quality Management System, emphasizing its ability to maintain the highest standards throughout the design, development, production, and distribution processes. This certification not only validates the company's capability to consistently meet customer and regulatory requirements, but also reinforces its position as a reliable partner for medical device manufacturers worldwide.

"We are thrilled to announce our ISO 13485 certification, a milestone that reflects our relentless pursuit of quality, safety, and reliability in all aspects of our operations,” said Daniel Slavin, President and CEO at Dordan Manufacturing. “Dordan is a sixty-two-year-old family company that began in a store front in Chicago. I’m very proud of our evolution from such modest origins to becoming a high-quality medical thermoformer that provides innovative, reliable, and compliant packaging to medical device manufacturers.”

Dordan Manufacturing's ISO 13485: 2016 certification not only reinforces its position as a leader in the packaging industry, but also underscores its readiness to meet the evolving needs and stringent requirements of the medical device sector.

For more information about Dordan Manufacturing and its medical packaging solutions, visit

About Dordan Manufacturing: Dordan Manufacturing is a full-service thermoforming company with in house design, tooling, and manufacturing. Dordan is ISO 9001 certified and equipped with an ISO Class 8 cleanroom for thermoforming medical packaging. Family owned and operated for over 60-years, Dordan delivers tailored packaging solutions that meet the unique needs of its diverse clientele.

Dordan's ISO class 8 cleanroomAbove: Dordan's ISO Class 8 cleanroom for manufacturing medical device packaging

Topics: ISO 13485, ISO class 8 cleanroom, cleanroom medical packaging