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.
Certificates
Certificate ISO 13485:2016
ISO 13485 2016 MDSAP
EC Certificate MDR