RISE Medical Notified Body AB

RISE Medical Notified Body (RISE MNB) is your personal partner on the road to market access in the EU. We support the development and innovation of medical devices by offering you as a manufacturer a close customer relationship, with good accessibility and communication, and a clear and efficient certification process. RISE MNB is a notified body for medical devices according to MDR 2017/745, as well as accredited for certification according to ISO 13485. We carry out conformity assessment of medical devices within several product groups, including: – Software – Devices with measuring function – Medical aids – Dental products – Sterile products We handle products of risk classes Is, Im, Ir, IIa and IIb. You can find our codes in NANDO: https://webgate.ec.europa.eu/single-market-compliance-space/notified-bodies/notifications/1006451?organizationVersion=1 RISE MNB handles applications, documentation and communication in Swedish and English. Welcome with your request: https://www.ri.se/en/mnb/mdr-certification/application-procedure If you want to change your notified body to RISE MNB, you will find information about voluntary change here: https://www.ri.se/en/mnb/mdr-certification/voluntary-change