JANA Life Sciences is proud to announce that it has been certified to ISO 13485:2016 in addition to its already implemented ISO 9001:2015, enabling the company to provide certified technical services, including technical documentation, to life science companies, particularly those focused on medical devices.
JANA Life Sciences, a division of JANA, Inc., announced today that it has been officially certified to ISO 13485:2016 after completing an extensive application and preparatory effort, including a series of mock audits. This certification provides life science and medical device companies with the assurance that their outsourcing partner is able to work in a fashion congruent to their needs and aligned to the requirements of the FDA and other regulatory authorities around the world.
“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.”
For more information about JANA Life Sciences or the services that we provide, please feel free to contact JANA at +1 (210) 616-0083, or visit our website at janalifesciences.com. We look forward to our continued partnership.