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Multi-centre research

Same study replicated with or without subcontractors

What it is

A systematic investigation that is conducted according to a single Clinical Investigation Plan and takes place at two or more investigation sites in one or more human subjects, undertaken to assess the safety or performance of a medical device.

Expected outcome

A report of the investigation outcome showing relevant data of the medical device studied. The data can be used for assessment of the safety and/or performance of the device and as clinical data required for CE-marking of the device.

Requirements

Essential documentation required according to the SS-EN ISO 14155:2011, Annex E.

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