The first fully transparent, FDA-cleared mask produced in the USA is made possible through a manufacturing partnership between ClearMask LLC, Xometry, and PKG Inc.
PKG Inc. announces agreement with Adventus Venture, a medical device incubator, to finalize development and manufacturing plans for two companies in their portfolio: Allevion Therapeutics and Pressao Medical. PKG Inc. develops complex and high-tech products for healthcare, aerospace, industrial, and government markets. In addition to the primary business model that supports Fortune 500 customers, PKG supports the incubation and acceleration of medical device start-up companies.
PKG, a privately-owned contract manufacturing and engineering company developing high-end medical and aerospace equipment, announced their registration with the FDA as an establishment producing medical personal protection equipment (PPE), such as surgical masks. PKG also announced the completion of the transfer of its ISO 13485:2016 and ISO 9001:2015 compliance certificates that encompasses the design, development, and production of its devices.
The TÜV SÜD ISO 13485:2016 certification is for the contract design, development, and manufacture of non-implantable OEM system-level medical systems, subassemblies, and components for the areas of diagnostics, imaging, patient treatment, monitoring, and surgical devices. This certification is from TÜV SÜD, one of the few organizations recognized as a designated body under the new European Medical Device Regulation (MDR). It enables PKG to leverage its research, development, and manufacturing strengths for multiple new products addressing novel indications as we advance. TÜV SÜD’s MDR designation will also ensure the continuity of regulatory compliance and support post-MDR implementation per European Union Directives on medical devices.
The TÜV SÜD ISO 9001:2015 certification is for the contract design, development, and manufacture of turnkey system-level aerospace, government, and industrial devices with expertise in human-machine interfaces.
“PKG has been diligently working to achieve these milestones for our products manufactured at our factory in Meridian.”, said Almir Garibovic, CEO of PKG. “These events continue to strengthen PKG’s position as the future leader in state-of-the-art medical device development and manufacture for our customers. We are excited to continue delivering innovative medical devices and enable us to fulfill our vision and values.”
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TÜV SÜD is a premium quality, safety, and sustainability solutions provider specializing in testing, inspection, auditing, certification, training, and knowledge services. Since 1866, the company has remained committed to its founding principle of protecting people, property, and the environment from technology-related risks. Headquartered in Munich, Germany, TÜV SÜD is represented in more than 1,000 locations worldwide. TÜV SÜD operates globally with a team of more than 24,000 multidisciplinary experts recognized as specialists in their respective fields. By combining impartial expertise with invaluable insights, the company adds tangible value to businesses, consumers, and the environment. TÜV SÜD aims to support customers with a comprehensive suite of services worldwide to increase efficiency, reduce costs, and manage risk. Visit www.tuvsud.com
Please join PKG at Booth # 3772 South, McCormick Place in Chicago, IL from November 26 - 29, 2018 during the annual RSNA Exhibition. PKG will be presenting new technologies and manufacturing methods developed by our engineers to save time and cost for our end customers. We will have expert staff on site, so bring your questions and we'll be sure to have answers. We look forward to speaking with you.
Please join PKG at Booth # 7961 North - Hall B, McCormick Place in Chicago, IL from November 26 through December 1, 2017 during the annual RSNA Exhibition. PKG will be presenting new technologies and manufacturing methods developed by our engineers to save time and cost for our end customers. We will have expert staff on site, so bring your questions and we'll be sure to have answers. We look forward to speaking with you.