FDA 510(k), SFDA Cina, CMDR Canada, JPAL Giappone, KFDA Corea, ANVISA Brasile, CE Unione Europea, EVICR.net, Ministero della Salute, marcatura CE, Authorized Representative, Clinical trial protocols

Consultancy for medical and healthcare companies

An international pass for the manufacturer

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CE MARKING MEDICAL DEVICES - EUROPEAN AUTHORIZED REPRESENTATIVE

ISOplan offers qualified and operative assistance on all aspects of the CE marking of the Medical Devices.

Authorized Representative Service
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 analysis
ISOplan's medical device experts determine risk classification and assist in preparing the mandatory documents to comply with ISO

Technical File
ISOplan's medical device experts assist in preparing the mandatory documents to comply with the directive. Some examples:

Essential requirements check list
Applicable standards
Product description
Software validation, verification and testing
Test Check List
Labelling