Notified Body for Europe
DNV Nemko Presafe has been appointed a Notified Body for Medical Device Directives and issues CE-certificates.
We are your local partner
By contacting your local Nemko team you get access to our experts. They are handling your projects and following up the delivery. Nemko has test facilities for healthcare equipment in America, Europe and Asia.
- IEC 60601-1 (General requirements for safety), IEC 60601-1-xx (Collateral) and IEC 60601-2-xx (Particular) series of standards. In addition, Nemko can assist you to ensure product compliance within more than 50 part 2 (Particular) standards
- CB certificates , 52 participating countries
- ISO 13485 and 9001 certificates
- EMC and telecom testing
- RoHS testing
- Reach and WEEE services
- Climatic and environmental testing