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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.

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

Clinical Investigations

  • Pre and post-marketing clinical investigation plans

  • Global management of clinical investigations

  • Inclusion and follow-up of patients or healthy volunteers

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