Aneva Italia offer regulatory services for producers and manufacturers of medical devices, as follow:

• Drafting of the technical documentation required to obtain the CE marking.
• National and international registration procedure for medical devices and assistance for marketing and set-up activities.
• Contact management with National and International Notified Bodies and competent Authorities.
• Logistic support: contacts with customs and preparation of the documents necessary for EU/non-EU import/export.
• Drafting, editing and updating of:
• Technical files
• Design Dossiers for class III medical devices
• Risk Management Plan, Analysis and Report
• Clinical evaluation reports (CER)
• Documentation supporting the absence of FIM action of a medical device
• Theoretical assessment of the toxicological profile of a medical device
• Rationale of the tests performed on a medical device, in order to give evidence of a "stepwise" approach, as described in the ISO 10993-10 standard
• Post-market surveillance and post-market clinical follow up, according to the provisions of Directive 93/42/ EEC, Regulation 2017/745 (EU) and other relevant laws
• Substitute declarations in accordance with horizontal and vertical sector regulations
• Coordination and monitoring of CLINICAL INVESTIGATIONS on medical devices of each risk class, in accordance with EN ISO 14155 and ICH-GCP guidelines. Assistance with the stipulation of insurance policies.
• Advisory services for labelling and instructions for use.
• Consultancy concerning the legislation governing printed/advertising material.
• Paperwork for advertising/scientific information.
• Contacts with ISO/IEC 17025 accredited laboratories.
• Amendments, renewals, extensions, following the registration phase of the medical device.
• Consulting services to companies in their certification process, and drafting of the documentation necessary for the fulfilment of the certification offer (forms, rational of the mechanism of action, etc.).