October 19, 2020
Beverly, MA — (October 19, 2020) – Sciessent today announced that its quality management system is compliant to the latest International Organization for Standardization’s (ISO) 13485 standard, which demonstrates a company’s ability to provide materials that consistently meet customer and applicable regulatory requirements in the medical device industry.
There is tremendous pressure on medical device manufacturers to deliver products that are both safe and effective. Establishing and maintaining a quality management system is fundamental to instilling quality throughout a product’s design and manufacturing processes and maintaining compliance with global regulations. Recognizing that device manufacturers increasingly rely on any number of suppliers to provide materials for their finished products, ISO updated its standard in 2016 to place greater emphasis on risk management, including requirements for manufacturers to hold their suppliers responsible for establishing quality systems and processes.
As a supplier of antimicrobial solutions to medical device manufacturers, Sciessent has always been strongly committed to the quality of its products. Over the years the company has strengthened its quality management system, taking steps to ensure it aligns with evolving ISO 13485 requirements. This ensures a consistent supply of high-quality antimicrobials to the medical device industry and helps device manufacturers quickly get their products approved and into market.
“We feel it is important, as a supplier, that our customers in the medical device industry feel confident in our quality management system and processes,” said Lise Moloney, Director, Business Development – Healthcare, Sciessent. “By maintaining a system compliant to the latest ISO 13485 standard, we strive for continuous improvement of our solutions.”
Sciessent is a leading provider of customized antimicrobial solutions that enhance the value of customers’ products. Agion antimicrobial solutions from Sciessent have been incorporated into a wide range of healthcare, industrial, and consumer applications, including medical devices such as central venous catheters and IV access ports, drinking water applications like water filters and ice making equipment, and textiles and apparel. For more information, please visit www.sciessent.com.