JANA Life Sciences is a division of JANA, Inc. Today, it officially received ISO 13485:2016 certification. This followed a thorough application and preparation process. It also included several mock audits. This certification assures life science and medical device companies. It confirms their outsourcing partner can meet their needs. It also aligns with FDA and global regulatory requirements.
“JANA’s business is built on producing technical documentation of the highest quality, which can only be assured through a sound quality management system,” says VP of Operations, Jeff Brown. “Although JANA has been certified to ISO 9001 for over 20 years (in addition to AS9100D), being certified to ISO 13485 further establishes the same commitment and quality that we aim to bring to life sciences, especially in the area of medtech.”
JANA Life Sciences President Ronald B. (Ron) Niland conveyed that, “It not only demonstrates our commitment to excellence, but it also gives us the North Star that will guide the build-out of our division for years to come. We are no doubt undergoing a technological revolution, but especially in the life sciences industry. We are proud to be able to help accelerate a broad array of cutting-edge technological developments. We’re most proud of the work we’re doing in the areas of radiography and radiotherapy, especially when it comes to treating cancer patients globally.”
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We look forward to our continued partnership.
