Select Page

ISO 13485 and MDR

Home 9 News 9 ISO 13485 and MDR

According to EU Regulation (EC) 2017/745 (MDR) and US 21 CFR 820 covering medical devices, manufacturers must demonstrate that the selected critical suppliers, contractors, and consultants meet all specified requirements, including quality requirements. These regulations hold manufacturers fully responsible for all outsourced processes. Fulfilling this obligation requires an understanding of and the ability to control every aspect of the supply chain, including the materials used, the impact manufacturing processes have on final products, and whether any impurities found in the materials used can affect end users. The state-of-the-art for medical devices in the EU, and soon also in the US, is to adhere to the ISO 13485:2016 quality management systems standard.

SAXOCON is an ISO 13485:2016 certified toxicological service supplier.

As a manufacturer, having confidence in your suppliers allows you to focus on your manufacturing processes and get your products approved and ready for market as quickly as possible. In 2021, SAXOCON was ISO 13485:2016 certified by BSI, allowing us to serve as a critical supplier of toxicological evaluation services. Our quality management system ensures that we have the right resources, competencies, procedures, and processes to provide consistent and quality-controlled services. Using us as a supplier of high-quality toxicological services gives you the peace of mind that comes with having one less thing to worry about at your next audit.

Obtaining certification is not a one-off event. To continue being ISO certified, BSI will audit us annually, and we are committed to continually investing in developing and improving our quality management system.

Learn more about how our certified services can support your business here.