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Regulatory analysis and strategy

We help you with strategic analysis and advice (medical device classification, intended use, market access, ressources, …).

Gap Analysis and compliance

Regulatory and technical inventory to identify deviations and bring you back into compliance.

Quality Management System

Evaluation of internal practices and we help you building procedures with your teams.

Technical File

We help your technical teams to build and maintain your technical file. Including Risk analysis, Usability analysis, compliance to IEC 62304, testing, and so on.

Clinical approach

Clinical evaluation plan and report, and Post market surveillance.

Standards analysis and monitoring

Standards requirements to operational requirements translation, in numeric format.

Software project management and development

Especially with IEC 62304 compliance.

Training and specific support

For all your teams (management, quality, regulatory or technical).

Fixed-price contract or by delegation

We adapt your way !

Let’s work together