MEDICAL DEVICES

A strategic and original partnership

Thanks to an original partnership bringing together complementary expertise,
we support you from the early - and decisive - phases of your projects

Support for the design and development of Medical Devices

• User needs analysis

• Functional analysis

• Cognitive exploration and contextual analysis

• User Failure Mode and Effects Analyses

Human Factor and usability studies

• Formative studies

The formative studies focus on the evaluation of the concepts and design options for the future medical device with targeted users.

• Summative studies

Summative evaluations are the formal validation studies performed for the final version of the medical device.

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Strategy and Regulatory Affairs for Medical Devices

• Regulatory strategy for CE marking and export (FDA, Health Canada)

• Regulatory compliance audits and support for corrective actions

• Gap analysis for clinical and pre-clinical data

• Clinical Evaluation Report

• Impact analysis of post-marketing changes

• PMS / PMCF plan and report

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Clinical Investigations

• Pre and post-marketing clinical investigation plans

• Global management of clinical investigations

• Inclusion and follow-up of patients or healthy volunteers