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Our commitment

Below you can find our different certifications for our quality system and our products. 

  • RaySearch Laboratories AB is a registered manufacturer of medical device software on the European, US, Canadian and Australian markets.
  • We maintain ISO 13485:2016 certification and are audited every year by our Notified Body Intertek Semko AB.
  • Our Quality system is also compliant with ISO 14971:2007.
  • RaySearch is fully compliant with 21 CFR Part 820, US FDA Quality Systems Regulations. View our Establishment Registration on the FDA website.
  • All software is compliant to IEC 61217, 62083, 62304 and 62366 standards. 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.



Certificate 13485;2016 en
ISO 13485-2003 CMDCAS MED-0082e
EC Certificate A2 41314834-02 2017-07-17

Product Certifications and Approvals

MDD Product List
RayStation 510(k) (Search for device "RayStation")
RayDose 510(k) (Search for device "RayDose")
RayAutoplan (Shareplan) 510(k)
Canadian Medical Device Licenses (use MDALL online query for Company Name RaySearch)

Australian ARTG entries