ABOUT US VISION AND MISSION TECHNICAL AND LEGAL SERVICES PUBLICATIONS PARTNERSHIPS CONTACT US


Technical & Legal Services

Our Services
Design and Review of
Technical Files for CE Mark
of Medical Devices

Research, Development
and Selection
• Research and selection of Materials
and Methods
• Design, Management and Control
of White Chambers
Engineering
Selection and Setting of Trials
• Mechanical
• Chemical
• Technological
• Biochemical
• etc.
Clinical and Animal
Experimentation
Study and Preparation
of Risk Analysis
Implementation of
production cycles
Design or Adaptation of Medical
Quality System(ISO 13485)
• Management Procedures
• Working instructions
• Forms
Design or Adaptation of Medical Quality guide
Audits for third parties
qualification and/or for
surveillance
• Assistance and preparation
for inspecting visits
• Assistance to Audits of Notified Bodies
Assistance to solve
Non Conformities
Legal assistance
Preparation and adaptation
of contracting Forms
• Supply
• Technical files
• Responsibility sharing
• Privacy guide
• Relationships with Distributors
Specialised Legal, Judiciary and Extra-judiciary Assistance
Activities for procurements at Ministry of Health and Consulates
• Requests of Attestation of CE Mark
• Authentication for Export
Technical consultation in Legal domain
Relationships with Customs Authorities
Assistance with Trademarks
and Licenses
Partnerships and Formation
Relationships with Universities and Research Institutes
Inspections on behalf of National Notified Body
Lectures at the National
Notified Body
Tailored Formation
Other sectors
Trademarks and Licenses
• HACCP guide
• Management System
• Risk Analysis
Food (HACCP)
"Borderline" products




ENCON Engineering & Consulting® s.a.s. - Numero iscrizione CCIAA Roma, Cod. Fiscale e Partita IVA : 07918581005 - Copyright 2010. All Rights reserved. | Web Site designed by XODIUM