Solutions
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 and prepare your teams to build and maintain your technical file:
Compliance with IEC 62304 and IEC 82304 for your software systems
Risk management following ISO 14971, including cybersecurity risks and specific AI-related risks
Usability according to IEC 62366
Requirements of the medical regulation (MDR), electro-medical standards (60601 family), biocompatibility, and all specific and particular standards
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 !