Medical Devices & Food
INTEXO in the Medical Devices & Food sector, offers a complete range of regulatory, marketing,
ISO and Quality Management solutions, through the synergy between internal professionals
and a panel composed of important experts in the fields.
Regulatory Analysis Strategies & Market Authorization
- Pre-certification/pre-authorization strategic planning for regulatory and technical-scientific placement;
- Interaction with scientific and institutional stakeholders;
- Power of Attorney & Representation with Competent Authorities, Notified Bodies and Certification Bodies, including the European Authorised Representative role;
- National and UE Health legislation monitoring, continuous and specific update on the legislative evolution in the medical devices and food fields;
- Product development: medical devices, food supplements and foods for special medical purpose;
- Advertising and promotion for medical devices and food;
- Due diligence: conformity assessment of technical/regulatory documentation to applicable requirements;
- Drawing-up/support/update of marketing authorization documentation and product Technical Files;
- Conformity assessment of labels and artworks;
- Gap analysis and compliance to the new Medical Devices Regulation;
- Quality Management Systems: provision, drawing-up of Quality Manual and SOPs, upgrading to the recent ISO 9001:2015 and ISO 13485:2016;
- Strategic consultancy for the development of clinical studies functional to the approval of health claims by EFSA;
- Entry and maintenance of medical devices records in the Italian Ministry of Health Database.
Product Regulatory Maintenance
- Assistance in import-export administrative and regulatory procedures and issue of free-sale certificates;
- Variations and renewals, and related administrative follow-up until the procedure closure;
- Support in CE marking and ISO audits, pre-audits;
- Support in CAPA management and in the resolution of System and Product Non-Conformities;
- Support for Clinical Validations;
- Maintenance of Quality Systems;
- Construction, maintenance and back-up of the Vigilance and Surveillance System (for Medical Devices): read more Vigilance services
