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ISO 13485 and MDR

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MDR & ISO 13485

According to EU Regulation (EC) 2017/745 (MDR) and US 21 CFR 820 covering medical devices, manufacturers must demonstrate that their 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 understanding and monitoring every aspect of the supply chain, including the materials used, the impacts manufacturing processes can 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 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 lets you focus on your manufacturing processes and getting your products approved and ready for market as quickly as possible. Since 2021, SAXOCON has been ISO 13485:2016 certified, allowing us to serve as a critical supplier of toxicological evaluation services. Our quality management system ensures 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 peace of mind and one less thing to worry about at your next audit.

Obtaining ISO certification is not a one-off event; it requires regular audits by BSI. Therefore, 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.