LANGUAGE About us Products Events Media Careers Contact REGULATORY The healthcare industry is governed by standards and regulations defining the technical requirements for medical packaging materials. With sales in more than 70 countries and a Regulatory Affairs department in place to track all changes to regulations, we strive to maintain the best of compliance for all the products we bring to market. Quality Control, Regulatory Affairs and Risk Management ISO 13485: 2016 quality system Packaging materials and Preformed Sterile Barrier System in compliance with ISO 11607-1 and EN ISO 11607-1 requirements Membership to Sterile Barrier Association, a member to Eucomed Dedicated resources for risk management & regulatory affairs Our products are tested for bioburden, cytotoxicity, sterilization compatibility, aging and much more. Industrial Performance We dedicate our machines to healthcare substrates only, for optimal process stability and minimal risk of cross- contamination. We run our equipment with a key focus on continuity of production and consistency of products. More than 20 million € have been spent over the last 10 years to develop our tooling and support continuous improvement in our manufacturing processes. Product Performance Safety and consistency are two key assets of our products We are the market reference for the design of tailor-made solutions to customer-driven technical requirements. We take into account our client's process conditions to deliver products that will help them in improving performance, design or value. Our current product portfolio is the result of years of learning and partnering with leading companies of the medical device and pouch making industry, and bringing successful solutions to their packaging needs. Accreditations of Manufacturing Sites Palalda plant: ISO 13485 : 2016 ISO 50001 : 2011 Brno site: ISO 13485 : 2016 ISO 9001 : 2015 Charleston site: FDA 21 CFR 820 Suzhou site: ISO 13485 : 2016 © All Rights Reserved, STERIMED GTC FAQ Contact Patient Safety Forum Pack Design Day This site uses cookies and gives you control over what you want to activate OK, accept all Deny all cookies Personalize