Medical Devices & Food

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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

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