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