We use cookies to help provide you with the best possible online experience. Learn more I APPROVE COOKIES BOOK A DEMO EN MENU QUALITY IS A MUST IN EVERYTHING WE DO PATIENT SAFETY FIRST, ALWAYS Our commitment Below you can find our different certifications for our quality system and our products. RaySearch Laboratories AB (publ) is a registered manufacturer of medical device software on all major markets. We maintain ISO 13485:2016 certification and are audited every year by our Notified Body Intertek Semko AB. RaySearch is fully compliant with 21 CFR Part 820, US FDA Quality Systems Regulations. View our Establishment Registration on the FDA website. All medical device software is compliant to ISO 14971, IEC 61217, 62083, 62304 and 62366. RayStation is also compliant to IEC 62274. This contributes to our state-of-the-art patient safety. It also allows for collaboration with existing and new partners and easy integration into their systems. RaySearch is a proud member of the standardisation committee ”Kvalitetsledning- och riskhanteringssystem samt andra tillhörande standarder för medicinteknik”. Certificates Certificate ISO 13485:2016 ISO 13485:2016 MDSAP EC Certificate MDD EC Certificate MDR RAYSEARCH AROUND THE GLOBE CONTACT US Get in touch with someone from our organization ABOUT How we advance cancer treatment through software CAREER Boost your career and find out more about RaySearch as an employer SUBSCRIBE Be first to know about new features, breaking news and financial statements. PRESS AND FINANCIAL NEWS PRODUCT NEWS FIND US HERE Twitter Linkedin YouTube © RaySearch Laboratories 2021