CE MARKING MEDICAL DEVICES - EUROPEAN AUTHORIZED REPRESENTATIVE
ISOplan offers qualified and operative assistance on all aspects of the CE marking of the Medical Devices.
Through its office, ISOplan offers customers European
Authorized Representative Services in accordance with the
requirements of the Medical and IVD Device Directive.
Risk assessment and
ISOplan's medical device experts determine risk
classification and assist in preparing the mandatory documents
to comply with ISO
ISOplan's medical device experts assist in preparing the mandatory documents
to comply with the directive. Some examples: