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ISO 13485 recertification reinforces Birk’s commitment to excellence in medical device manufacturing
This press release is also available online here.
EAST LYME, CT, UNITED STATES, February 4, 2025 – Birk Manufacturing, a leading provider of advanced flexible heating solutions, proudly announces their successful ISO 13485 recertification. This achievement underscores their commitment to the highest quality, precision, and traceability for medical device manufacturing.
ISO 13485 is the internationally recognized standard for quality management systems specific to the medical device industry. It focuses on risk management, product traceability, and stringent regulatory compliance throughout the design, development, production, and delivery of a product.
“Achieving ISO 13485 recertification is a testament to the dedication and expertise of our entire team,” said Carleton Birk, President of Birk Manufacturing. “Their commitment to excellence ensures that we consistently deliver safe, high-quality solutions to our customers in the medical device industry. I am immensely proud of their efforts and their role in advancing our reputation as a trusted partner.”
For Birk’s customers, this milestone provides assurance that they are working with a highly trusted partner that maintains strict adherence to industry regulations, ensuring their thermal management solutions are both safe and effective. From blood analyzers to imaging devices to incubators and more, Birk’s custom-engineered flexible heaters and thermal solutions offer reliable and precise temperature control.
About Birk Manufacturing
Birk Manufacturing designs and produces high-quality flexible heaters and thermal solutions for the medical, aerospace, defense, semiconductor industries and more. Birk is committed to superior quality and dedicated to outstanding service. They serve their customers through engineering excellence, innovative solutions and precision manufacturing.
For more information about Birk’s medical manufacturing capabilities, check out our Medical Industry page or reach out to talk to our team.
