Latest news with #ISO13485:2016
Yahoo
18 hours ago
- Business
- Yahoo
DuPont Expands Healthcare Manufacturing Site in Costa Rica, Adding Sterile Packaging Capacity
The 16,000-square-foot expansion enhances DuPont's global sterile operations, increases the capacity of the manufacturing site's existing medical tubing operations, and enables Costa Rica's first-ever production of sterile healthcare packaging. WILMINGTON, Del., June 5, 2025 /PRNewswire/ -- DuPont (NYSE: DD) today announced that it has expanded its sterile operations via an addition to its healthcare manufacturing facility in Heredia, Costa Rica, enabling the site to produce sterile packaging for the global medical device industry while also increasing the capacity of the site's existing medical tubing operations. To serve Healthcare customers in the Caribbean and more broadly across the Americas, the Heredia operation has expanded by 16,000 square feet. The new space accommodates additional extrusion equipment and production lines, enabling production of sterile packaging leveraging Tyvek® – such as pouches, header bags and lids – and increasing DuPont's extruded tubing production capacity. The new expansion is ISO 13485:2016 and ISO 9001:2015 certified, with its technical, assembly and packaging staff adhering to the highest quality standards and protocols. To support current and new customers, the facility is operating on a 24/7 production schedule. "With this expansion, we are now the first company in Costa Rica and the Caribbean to produce fluid management and sterile packaging offerings for the medical device industry," said James Chambers, Senior Vice President and General Manager for Fluids & Flexibles at Spectrum Plastics Group, A DuPont Business. "This significantly enhances our robust, growing portfolio of unmatched offerings and capabilities as a trusted supply chain partner to leading global healthcare companies." DuPont's products, services and expertise for the healthcare industry include extruded tubing and subassemblies, advanced catheter assembly, medical balloons, skin contact devices, smart wearables, additive manufacturing, laser processing, precision injection-molding, medical device fabrication, machining and sterile packaging enabled by Tyvek®. Combining medical-grade performance materials, component and device solutions, and innovative technology, DuPont offers full-service, comprehensive solutions that support a range of healthcare applications. Learn more about DuPont's healthcare solutions at About Spectrum Plastics Group, A DuPont Business Acquired by DuPont in August 2023, Spectrum Plastics Group, A DuPont Business, brings over 60 years of expertise in advanced polymer processing and medical device manufacturing. The company specializes in precision extrusion, specialty injection molding, blown film extrusion and conversion, medical balloon fabrication, laser processing, additive manufacturing, and complex catheter and device assembly. Spectrum is recognized as a leading trusted supplier for the development and production manufacturing of critical polymer-based components and finished devices for the medical device market and other high-performance applications. With global facilities and more than 1 million square feet of manufacturing space, Spectrum delivers proven quality, innovation and technical excellence to solve the most demanding customer challenges. The company supports a broad range of healthcare applications across the biopharmaceutical processing, medical device and pharmaceutical markets. More information can be found at About DuPont DuPont (NYSE: DD) is a global innovation leader with technology-based materials and solutions that help transform industries and everyday life. Our employees apply diverse science and expertise to help customers advance their best ideas and deliver essential innovations in key markets including electronics, transportation, construction, water, healthcare and worker safety. More information about the company, its businesses and solutions can be found at Investors can access information included on the Investor Relations section of the website at DuPont™, the DuPont Oval Logo, and all trademarks and service marks denoted with ™, SM or ® are owned by affiliates of DuPont de Nemours, Inc. unless otherwise noted. View original content to download multimedia: SOURCE DuPont
Mid East Info
27-05-2025
- Business
- Mid East Info
KFSHRC's 3D Medical Printing: Faster Surgeries, Fewer Complications
Riyadh: King Faisal Specialist Hospital & Research Centre (KFSHRC) has earned ISO 13485:2016 certification for its 3D Printing Services Department. This ISO certification represents the highest global standards for quality management systems in the design and manufacture of medical devices. It reflects the KFSHRC's strength in delivering innovative, custom-made solutions in complex clinical settings with rigorous quality control and assurance. KFSHRC's 3D Printing Services Department has become a cornerstone of the hospital's precision healthcare ecosystem. The department uses advanced additive manufacturing to produce patient-specific anatomical models, surgical guides, prosthetics and implants to improve surgical planning, reduce intraoperative risks, and augment clinical outcomes. In 2023, the department produced over 1,100 physical models and more than 5,000 digital simulations, which shortened average surgery time by 30% and reduced complications by 85%, significantly improving patient satisfaction. KFSHRC's achievements in this field have also garnered international recognition. The hospital was ranked among the top 20 Saudi government entities in the Emerging Technology Adoption Readiness Index for 2025. The Global Project Management Forum (GPMF) awarded its 3D Printing Project the 2024 Global Excellence Award in Technology Project Management. 'Our mission is to conduct cutting-edge, multidisciplinary research and integrate the innovative technologies into medical practice. Our expertise in 3D printing, artificial intelligence and robotics is combined to advance healthcare delivery. We are expanding our technology platforms and working towards our Kingdom's Vision 2030 to spin off a 3D printing medical technology company that would provide a broad healthtech and socioeconomic impact.' Notably, for the third consecutive year, KFSHRC has been ranked first in the Middle East and Africa and 15th globally in the list of the world's top 250 Academic Medical Centres. According to the 2025 Brand Finance rankings, it has been recognized as the most valuable healthcare brand in the Kingdom and the Middle East. Additionally, it was included in Newsweek magazine's World's Best Smart Hospitals list for 2025.
Yahoo
19-05-2025
- Business
- Yahoo
Resonetics® Invests in Nitinol Gun Drilling Capabilities Through Purchase of Assets from Medical Component Specialists
Establishes nitinol input tube operation to support premium, implant-grade tubing initiative and strengthen supply chain resilience NASHUA, N.H., May 19, 2025 /PRNewswire/ -- Resonetics® announced today that it has acquired the nitinol gun drilling operations and related assets of Medical Component Specialists' (MCS) New Boston, NH facility. This acquisition marks another key investment in Resonetics' comprehensive U.S.-based nitinol strategy. This transaction follows the meaningful steps that Resonetics has taken to expand the availability of material and supply of nitinol, a crucial material for the most innovative next generation medical devices. Gun drilling is a highly specialized machining operation that creates a precision hole along the center of a bar. This foundational manufacturing step in the production of high-performance nitinol tubing serves as the starting point for seamless-drawn nitinol tubing. MCS has been a supplier of nitinol input tubes in support of Resonetics' growing nitinol tubing business. MCS' automated long-stroke gun drilling process both drives efficiency and meets the exacting demands of the medical device industry. "Nitinol gun drilling is critical to our premium tubing initiative and our ability to improve material availability and reduce lead times for our customers," said Kevin Kelly, CEO of Resonetics. "Combined with the recent investments we've made in melt capacity and raw material and in-process inventory, this acquisition further reduces supply chain risk - all while supporting our long-term growth and innovation in nitinol." This investment also builds on Resonetics' recent nitinol tubing capability expansion in Bethel, Connecticut (see announcement) related to its acquisition of the former Memry Corp. and SAES Smart Materials, creating the broadest and most advanced nitinol portfolio in the industry (see announcement). By bringing gun drilling in-house, Resonetics ensures the precision, control, and flexibility needed for rapid prototyping and scalable manufacturing of complex implants and delivery systems. "As we expand our tubing and component capabilities, we remain committed to being an open-source supplier to both medical device OEMs and contract manufacturers," added Kelly. "We welcome partnerships with customers of all sizes, and we're focused on delivering the quality, responsiveness, and innovation that accelerates medical device breakthroughs." About ResoneticsFounded in 1987, Resonetics is a pioneer in advanced engineering and manufacturing solutions for the medical device industry. Resonetics is a leader in laser processing, nitinol manufacturing, thin-wall stainless steel, nitinol& precious metal tubing, and photochemical machining. With strategically located Lightspeed Labs® and AGILE Product Development® centers, Resonetics is committed to quality, speed, innovation, and a great customer experience. The company is ISO 13485:2016 certified with 17 facilities and more than 3,000 associates in the United States, Canada, Costa Rica, Israel, and Switzerland. Resonetics is backed by leading private equity firms Carlyle and GTCR. Learn more at About GTCRFounded in 1980, GTCR is a leading private equity firm that invests behind The Leaders Strategy™ – finding and partnering with management leaders in core domains to identify, acquire and build market-leading companies through organic growth and strategic acquisitions. GTCR is focused on investing in transformative growth in companies in the Business & Consumer Services, Financial Services & Technology, Healthcare and Technology, Media & Telecommunications sectors. Since its inception, GTCR has invested more than $30 billion in over 280 companies, and the firm currently manages $45 billion in equity capital. GTCR is based in Chicago with offices in New York and West Palm Beach. For more information, please visit Follow us on LinkedIn. About CarlyleCarlyle (NASDAQ: CG) is a global investment firm with deep industry expertise that deploys private capital across three business segments: Global Private Equity, Global Credit, and Carlyle AlpInvest. With $453 billion of assets under management as of March 31, 2025, Carlyle's purpose is to invest wisely and create value on behalf of its investors, portfolio companies, and the communities in which we live and invest. Carlyle employs more than 2,300 people in 29 offices across four continents. Further information is available at Follow Carlyle on X @OneCarlyle and LinkedIn at The Carlyle Group. View original content to download multimedia: SOURCE Resonetics, LLC Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Ottawa Citizen
25-04-2025
- Business
- Ottawa Citizen
HARMAN and KT altimedia Announce Strategic Partnership to Provide Innovative Solutions for Next Generation Media Services
Article content Article content Article content STAMFORD, Conn. — HARMAN International, a wholly-owned subsidiary of Samsung Electronics Co., Ltd., focused on connected technologies today announced a new partnership with KT altimedia, Korea's leading provider of digital media service solutions for PayTV operators, specializing in middleware, content security, user experience, and cloud-based UI. Led by HARMAN's Digital Transformation Solutions business unit, this partnership aims to drive innovation in digital media services and accelerate the expansion of PayTV solutions across global markets. Article content HARMAN Digital Transformation Solutions brings decades of expertise in global media technologies, leveraging its deep industry relationships to introduce new media trends and cutting-edge solutions. HARMAN aims to enhance PayTV experiences, improve content security, and support the digital transformation of media services. Article content 'Our partnership with KT altimedia marks an exciting step forward in redefining PayTV experiences and accelerating media innovation,' said Vikas Gupta, Executive Vice President and General Manager at HARMAN Digital Transformation Solutions. 'By combining HARMAN's technology expertise with KT altimedia's industry-leading media services, we are poised to deliver cutting-edge, scalable solutions that will shape the future of digital media.' Article content 'Our strategic collaboration with HARMAN marks a significant milestone in expanding next-generation PayTV solutions in the global market,' stated Do Sa Park, CEO of KT altimedia. 'Backed by years of expertise in media platform technologies and service innovation, KT altimedia is committed to delivering flexible and cutting-edge solutions together with HARMAN to create new media experiences that exceed customer expectations.' Article content This partnership underscores HARMAN's ongoing commitment to pioneering digital transformation across various industries. By leveraging the strengths of both companies, HARMAN and KT altimedia are set to deliver next-generation PayTV solutions that cater to the evolving demands of customers. Article content HARMAN Digital Transformation Solutions is dedicated to blending the physical and digital to make technology more dynamic to serve the ever-changing human needs. Our team of over 7,000 employees in 45+ locations around the world are focused on transforming everyday experiences. Compliant and certified with international standard/ management system EN 9100:2018 / AS9100D, ISO 9001:2015, ISO 27001:2013, ISO 13485:2016 and appraised at CMMI-DEV 2.0 ML5, HARMAN partners with our customers to deliver a holistic experience – through the convergence of digital, cross channel user experience, cloud, mobility, insightful data and internet-of-things backed by scalable underlying IT platforms. Our global delivery approach, IPs, platforms and people allows us to deploy next-generation platforms, while delivering cost efficiencies and innovative solutions to help our clients achieve brilliant outcomes. To know more, please visit Article content Article content HARMAN ( designs and engineers connected products and solutions for automakers, consumers, and enterprises worldwide, including connected car systems, audio and visual products, enterprise automation solutions; and services supporting the Internet of Things. With leading brands including AKG®, Harman Kardon®, Infinity®, JBL®, Lexicon®, Mark Levinson® and Revel®, HARMAN is admired by audiophiles, musicians and the entertainment venues where they perform around the world. More than 50 million automobiles on the road today are equipped with HARMAN audio and connected car systems. Our software services power billions of mobile devices and systems that are connected, integrated and secure across all platforms, from work and home to car and mobile. HARMAN has a workforce of approximately 30,000 people across the Americas, Europe, and Asia. In 2017, HARMAN became a wholly owned subsidiary of Samsung Electronics Co., Ltd. Article content Founded in 1999, KT altimedia is a leading media platform company based in Korea, providing end-to-end multimedia solutions for PayTV operators worldwide. From device platforms for set-top boxes and mobile, to user-centric service applications, cloud-based UI/UX, and secure content protection systems (CAS/DRM), KT altimedia delivers integrated services powered by its own proprietary technologies—offering a strong foundation for global competitiveness. KT altimedia's solutions are deployed by major broadcasting and telecom operators across Asia, and Europe, supporting business expansion and operational efficiency. Its advanced security systems, UI management system, and remote management solutions empower operators to swiftly adapt to changing market demands while ensuring scalability, flexibility, and cost-effectiveness in today's rapidly evolving media landscape. Moving forward, KT altimedia will continue to lead media innovation through ongoing investment in R&D and global partnerships—positioning itself as a strategic partner for PayTV operators navigating the digital transformation of media services. Article content Article content Article content Article content Article content
Business Wire
24-04-2025
- Business
- Business Wire
HARMAN and KT altimedia Announce Strategic Partnership to Provide Innovative Solutions for Next Generation Media Services
STAMFORD, Conn.--(BUSINESS WIRE)-- HARMAN International, a wholly-owned subsidiary of Samsung Electronics Co., Ltd., focused on connected technologies today announced a new partnership with KT altimedia, Korea's leading provider of digital media service solutions for PayTV operators, specializing in middleware, content security, user experience, and cloud-based UI. Led by HARMAN's Digital Transformation Solutions business unit, this partnership aims to drive innovation in digital media services and accelerate the expansion of PayTV solutions across global markets. HARMAN Digital Transformation Solutions brings decades of expertise in global media technologies, leveraging its deep industry relationships to introduce new media trends and cutting-edge solutions. HARMAN aims to enhance PayTV experiences, improve content security, and support the digital transformation of media services. 'Our partnership with KT altimedia marks an exciting step forward in redefining PayTV experiences and accelerating media innovation,' said Vikas Gupta, Executive Vice President and General Manager at HARMAN Digital Transformation Solutions. 'By combining HARMAN's technology expertise with KT altimedia's industry-leading media services, we are poised to deliver cutting-edge, scalable solutions that will shape the future of digital media.' 'Our strategic collaboration with HARMAN marks a significant milestone in expanding next-generation PayTV solutions in the global market,' stated Do Sa Park, CEO of KT altimedia. 'Backed by years of expertise in media platform technologies and service innovation, KT altimedia is committed to delivering flexible and cutting-edge solutions together with HARMAN to create new media experiences that exceed customer expectations.' This partnership underscores HARMAN's ongoing commitment to pioneering digital transformation across various industries. By leveraging the strengths of both companies, HARMAN and KT altimedia are set to deliver next-generation PayTV solutions that cater to the evolving demands of customers. About HARMAN Digital Transformation Solutions HARMAN Digital Transformation Solutions is dedicated to blending the physical and digital to make technology more dynamic to serve the ever-changing human needs. Our team of over 7,000 employees in 45+ locations around the world are focused on transforming everyday experiences. Compliant and certified with international standard/ management system EN 9100:2018 / AS9100D, ISO 9001:2015, ISO 27001:2013, ISO 13485:2016 and appraised at CMMI-DEV 2.0 ML5, HARMAN partners with our customers to deliver a holistic experience – through the convergence of digital, cross channel user experience, cloud, mobility, insightful data and internet-of-things backed by scalable underlying IT platforms. Our global delivery approach, IPs, platforms and people allows us to deploy next-generation platforms, while delivering cost efficiencies and innovative solutions to help our clients achieve brilliant outcomes. To know more, please visit About HARMAN HARMAN ( designs and engineers connected products and solutions for automakers, consumers, and enterprises worldwide, including connected car systems, audio and visual products, enterprise automation solutions; and services supporting the Internet of Things. With leading brands including AKG®, Harman Kardon®, Infinity®, JBL®, Lexicon®, Mark Levinson® and Revel®, HARMAN is admired by audiophiles, musicians and the entertainment venues where they perform around the world. More than 50 million automobiles on the road today are equipped with HARMAN audio and connected car systems. Our software services power billions of mobile devices and systems that are connected, integrated and secure across all platforms, from work and home to car and mobile. HARMAN has a workforce of approximately 30,000 people across the Americas, Europe, and Asia. In 2017, HARMAN became a wholly owned subsidiary of Samsung Electronics Co., Ltd. About KT altimedia Founded in 1999, KT altimedia is a leading media platform company based in Korea, providing end-to-end multimedia solutions for PayTV operators worldwide. From device platforms for set-top boxes and mobile, to user-centric service applications, cloud-based UI/UX, and secure content protection systems (CAS/DRM), KT altimedia delivers integrated services powered by its own proprietary technologies—offering a strong foundation for global competitiveness. KT altimedia's solutions are deployed by major broadcasting and telecom operators across Asia, and Europe, supporting business expansion and operational efficiency. Its advanced security systems, UI management system, and remote management solutions empower operators to swiftly adapt to changing market demands while ensuring scalability, flexibility, and cost-effectiveness in today's rapidly evolving media landscape. Moving forward, KT altimedia will continue to lead media innovation through ongoing investment in R&D and global partnerships—positioning itself as a strategic partner for PayTV operators navigating the digital transformation of media services.
