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 ISO 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.
- RaySearch is a proud member of the standardisation committee ”Kvalitetsledning- och riskhanteringssystem samt andra tillhörande standarder för medicinteknik”.
Certificate 13485;2016 en
ISO 13485:2016 MDSAP 0080663-00
EC Certificate A2 41314834-03 2018-09-18