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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 software is compliant to ISP 14971, IEC 61217, 62083, 62274, 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.

 

Certificates

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

Product Certifications and Approvals

RayStation 510(k) (Search for device "RayStation")
Canadian Medical Device Licenses (use MDALL online query for Company Name RaySearch)

Australian ARTG entries

RayStation