Strouse is proud to announce that it has earned ISO 13485:2003 registration from SAI Global. The standard was designed to be used by organizations involved in the design, production, installation, and servicing of medical devices. As the healthcare and medical markets continue to solve more complex challenges, the ISO 13485 standard aims to serve as a framework for regulatory requirements through every step of a product’s life cycle.
“For years, Strouse has excelled in providing tight tolerance die cut adhesive components and assembled products to medical device manufacturers,” stated Sue Chambers, President and CEO of Strouse. “Achieving ISO 13485:2003 registration is a testament to our people and processes as we continue to support our organic growth in the healthcare and medical markets.”
Strouse works with organizations and projects of all sizes to help them design, develop, and manufacture medical devices and components, from untested concepts on napkin sketches to full manufacture and assembly of FDA approved medical devices for publicly traded companies. Medical device manufacturers look to Strouse to help them scale manufacturing to meet market demands from the design and testing phases to product launch through maturity.
In addition to earning ISO 13485: 2003 registration, Strouse’s quality management system is also registered to the ISO 9001: 2015 standard.
“With a focus on quality assurance and continuous improvement, Strouse has fostered a culture of constantly striving to be better in every aspect of our business,” said Denny Tichnell, Quality Manager at Strouse. “This can be seen across our entire organization from employee training programs to pre-production planning to our production processes and control plans for receiving raw materials through shipping finished products.”
Strouse is a die cut adhesive manufacturer with over 25 years of industry experience. Serving the medical, automotive, military, appliance, and renewable energy industries, Strouse continues to innovate. With a quality management system registered to ISO 9001:2015 and ISO 13485:2003 standards, Strouse not only has a commitment to quality but excellent customer service. A full team of design and development engineers allows Strouse to invest the necessary time and resources for each and every project. Located in Westminster, Maryland, Strouse can be contacted directly at 1-800-410-8273 or visit our website for more info at https://www.strouse.com/