Birk Manufacturing achieves ISO 13485 recertification

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,” says 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.