Aptar CSP Technologies, a leader in material science and active packaging solutions (part of AptarGroup, Inc.), earned the International Organization for Standardization ISO 13485:2016 certification for both its U.S. and France-based plants. These internationally recognized standards set the requirements for a quality management system specific to the medical device industry.
An ISO 13485-approved site ensures consistent design, development, production, installation, and delivery of medical devices that are safe for their intended purpose. The ISO certifications come at a critical time as the company is currently preparing for commercialization of a new medical device using its proprietary 3-Phase Activ-Polymer™ platform technology.
In addition to this imminent medical device commercialization, the company’s patented Activ-Film™ technology is currently integrated into implantable medical devices to control the microclimate of the device, extending use life and improving performance. The technology can also be engineered as a critical component of the overall delivery system.
“With this ISO certification, we are well-positioned to serve our current and future medical device partners,” said Badre Hammond, VP Commercial Operations, Aptar CSP Technologies. “As we broaden our portfolio of offerings, we continue to invest in our quality systems and operational excellence to support continued growth.”