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Clinical Study Design

Consulting
Pricing/Discount Options: Call #2
Unique Identifier: 63066211-34ea-4ff6-ae71-a6c75a43f1d3

Service Description

Consulting on the design of a clinical protocol for the clinical evaluation procedure to collect clinical data in support to the certification process throughout the lifecycle of the medical device. Application of MDCG 2020-1 principles in the design of the specif clinical study; MDCG 2020-1.

Keywords: Clinical investigation, clinical study, clinical evaluation procedure, CE certification process

Offerings: Research & Development Conformity & Compliance (certification, audit, corrective and preventive action, documentation, gap & risk analysis, etc.) Clinical Investigation Support (clinical studies & trials, coordination, design, feasibility, documentation, compliance, operations support)
TEF-Health Use Case Domain: all
Provider Logo

Provider & Contact

Provider Organisation Politecnico Di Milano (POLIMI)
Provider Country Italy
Published Email tef-health@polimi.it

Pricing is available to registered users. SMEs receive significant state-aid reductions (GBER) — or, depending on the call, free services during the funded project. Sign in or register to see the price for your organisation.

Operational Details

Service Inputs Study Objective, Primary and secondary goals; Methods
Service Outputs Report on the design of the clinical evaluation
Dependencies & Restrictions MDR
Service Standards EU Regulation 2017/745 , MDCG 2020-1
  • EU Regulation 2017/745
  • MDCG 2020-1

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