DEKRA is a European Notified Body (NB 0344) based in the Netherlands with expert resources located in the US, Europe, ASIA, South America and many other markets. Founded in 1925, DEKRA currently has over 48,000 employees around the globe.
DEKRA offers a range of certification services to support medical device manufacturers targeting global markets. Our medical services include - CE Marking under MDR and IVDR, ISO 13485 certification, MDSAP certification and Notified Body Opinion according to article 117. DEKRA can transfer your certificates for any service from another Notified Body and assume the current surveillance audits.